KR101916651B1 - Sinus illumination lightwire device - Google Patents

Abstract

The illumination wire medical device may include a long flexible housing, an illumination fiber, and a core wire extending through at least a portion of the housing, the core wire providing desired indentability and torque transfer. The illumination device also includes a connector assembly that interacts with the illuminating fiber to accommodate variations in length and to absorb applied force during use of the device and to send stray light away from the illuminating fibers of the device .

Description

[0001] SINUS ILLUMINATION LIGHTWIRE DEVICE [0002]

The present invention relates generally to medical devices, systems and methods, and more particularly to methods and apparatus for performing minimally invasive procedures that reduce the need to provide fluoroscopic or other radiographic transmission visualization.

The skull includes a series of cavities known as sinuses connected by passageways. The sinuses include frontal sinus, ethmoid sinus, sphenoid sinus, and maxillary sinus. The sinuses are padded with mucus-forming mucosal tissue and ultimately open into the nasal cavity. Usually, mucus produced by mucosal tissue is slowly released out of each sinus through an opening known as ostium. If mucosal tissue of one of these passages is infected for any reason, the exhausted gas through such passages may become clogged. Such blockage may be cyclic (resulting in the development of pain) or chronic. This disturbance of mucus discharge (e.g., occlusion of the sinus cavity) can lead to mucus constriction within the sinus. Chronic mucus stasis of the sinuses can cause damage to the sinus-pumping epithelium, with subsequent reduced oxygen partial pressure and microbial growth (e.g., sinus infection).

The term " sinusitis " refers to any inflammation or infection of the sinuses generally caused by bacteria, viruses, fungi (molds), allergies or combinations thereof. Chronic sinusitis, which lasts for more than 3 months, for example, is estimated to result in 18 million to 22 million visits to the clinic annually within the United States. Patients with sinusitis typically experience at least some of the following symptoms: headache or facial pain; Nasal congestion or post-nasal drainage; Difficulty breathing through one or both nostrils; Bad breath; And / or pain in the upper teeth.

One of the ways to treat sinusitis is by restoration of the lost mucus flow. Initial treatment is typically a medication that uses an anti-inflammatory agent to reduce inflammation and an antibiotic to treat the infection. A large number of patients do not respond to medication. Currently, the best standard for patients with chronic sinusitis that does not respond to medication is a corrective surgery called Functional Endoscopic Sinus Surgery (FESS).

During FESS, the endoscope is inserted into the nose and under visualization through the endoscope, the surgeon can remove diseased or enlarged tissue or bones, and can widen the pores of the sinus to restore the normal evacuation of the sinus. FESS procedures are typically performed on patients under general anesthesia.

Although FESS is still the best standard of care for surgical treatment of severe sinus disease, FESS has several drawbacks. For example, FESS can cause significant post-operative pain. In addition, some FESS procedures are associated with considerable postoperative hemorrhage, and as a result, nasal packing is often placed in the patient's nose for some period of time after surgery. Such nasal stuffing can be uncomfortable and can interfere with normal breathing, eating, drinking and the like. In addition, some patients have symptoms even after several FESS operations. In addition, some FESS procedures are associated with the risk of iatrogenic orbital, intracranial, and sinus-nose injuries. Many otolaryngologists view FESS as an option only for patients with severe sinus disease (eg, patients with significant abnormalities under CT scan). Thus, a patient with less severe disease may not be considered a candidate for FESS. One of the reasons that the FESS procedure can cause bleeding and pain is related to the fact that a device with a straight stiffness shaft is used. In order to target deep regions of the anatomical structure with such a linear stiffness mechanism, the surgeon may designate any anatomical structure that can be placed in the immediate path of the instrument, with or without ablation, regardless of whether such anatomical structure is part of the lesion It needs to be removed or otherwise manipulated.

New devices, systems and techniques are being developed for the treatment of sinusitis and other diseases of the ears, nose, throat and sinus. For example, various catheters, guidewires, and other devices that can be used to perform minimally invasive, minimally traumatic ear, nose, and throat surgeries have been described herein as " diagnosing sinusitis and other diseases of the ears, nose, and / or throat U.S. Patent Application No. 10 / 829,917, entitled " Devices, Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears, Nose and / or Throat, No. 10 / 912,578, entitled " Implantable Device and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders ", entitled " Implantable Device and Methods for Delivering Drugs and Other Materials to Treat Sinusitis and Other Diseases &number; No. 10 / 944,270 entitled " Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures ", entitled "; No. 11 / 037,548 entitled " Devices, Systems and Methods for Treating Diseases of the Ear, Nose and Throat ", entitled " Nose and Throat "; No. 11 / 116,118, entitled " Methods and Devices for Performing Procedures Within the Ear, Nose, Throat and Paranasal Sinuses ", entitled " . Each of these applications is hereby incorporated herein by reference in its entirety. Many of these novel devices, systems, and techniques are used to facilitate accurate positioning and movement of catheters, guide wires, and other devices within the ear, nose, throat, and sinuses, and to facilitate accurate positioning and movement of critical anatomy Can be used with endoscopes, radiopaque and / or electronic aids to avoid undesirable trauma or damage to enemy structures.

For example, in one novel procedure (referred to in the patent application as "Flexible Transnasal Sinus Intervention" or FTSI), an expanding catheter (eg, a balloon catheter or other type of expander) The catheter is advanced through the nose to a position within the parenchyma of the sinus or other location without requiring removal of the anatomical structure or surgical modification. The expanding catheter is then advanced through the pores or other anatomy In some cases, the tubular guide may initially be inserted through the nose and advanced to a position near the sinus cavity, and the guide wire may then be advanced through the tubular guide into the diseased sinus. The expanding catheter is then moved to a position where the expander (e.g., balloon) is located within the sinus cavity In some cases, such enlargement of the pore may include, but is not limited to, fracturing, moving, or otherwise expanding the bone structure surrounding the pore or adjacent the pore, Alternatively, in some procedures, a wash fluid and / or a therapeutic agent may be injected through the lumen of the expanding catheter and / or may be injected through another operating device (e.g., a guide wire, catheter, A catheter, a dilator, a balloon, a material syringe, a needle, an infuser, a cutter, a debrider, a microdriver, a hemostatic device, a cauterizer, a cryo-operating device, a heater, a heater, a cooler, , A light guide, a light therapy device, a drill, a string, a saw, etc.) may be inserted through a tubular guide and / or a guide wire to perform other treatments on the sinus or adjacent tissue during the same procedure in which FTSI is performed In FTSI procedures, structures and passageways other than the sinusoidal pores can be expanded using the aforementioned tools, as described in the references incorporated herein by reference, and tissue can be ablated or removed And that the bone can be restructured and that a drug or drug delivery system can be deployed. Thus, for purposes of this application, the term " FTSI " will generally be used to refer broadly to all such procedures, not just extensions of sinus pores.

In an FTSI procedure involving the positioning of the guide wire into the sinus, the placement of the guide wire is typically confirmed by visualizing the procedure, e.g., by fluoroscopy or other X-ray visualization techniques. Proper positioning of the tubular guide at a location near the sinus pore can also be confirmed through fluoroscopy. Reaching and accessing the target anatomical structure can be a difficult task in general, especially in the case of the patient because the anatomical structure can be variable and unpredictable. In addition, devices employed in medical procedures must be durable to withstand stresses due to unexpected problems as well as stresses during normal surgical conditions. There is a need for a method and apparatus for eliminating or reducing the need to use fluoroscopic visualization during such procedures in order to reduce radiation exposure to the patient undergoing the procedure and especially to the surgeon and other staff performing many of these types of procedures . There is also a need for a medical device that implements acceptable torque torquability and pushability. In addition, there is a need for a device having a structure that facilitates accommodating the force applied thereto. At least some of these objectives will be met by the present invention.

Briefly and in general, the present invention is directed to an apparatus and method for facilitating visualization of a target anatomical structure. In one approach, the device is embodied in an illumination device configured to be located at or adjacent to an anatomical structure within a patient's body. The illumination device may be employed to provide transmission illumination.

In one aspect, the illumination device is embodied as a long member having a proximal portion and a distal portion, wherein the distal portion is configured to be disposed at the intervening portion. A connector is configured in the proximal portion of the device. The elongate member may further include an internal bore for receiving a substructure of the apparatus.

In one embodiment,

A long flexible housing having a proximal end, a distal end configured to be positioned in a region within a patient's body, and a lumen extending from the proximal end to the distal end through the housing, ), The housing includes at least a first portion of a first material (e.g., a coil) and a second portion of a second material (e.g., a cable tube), wherein the first portion and the second portion The long flexible housing being joined together by a first joint and a second joint;

At least one illuminating fiber extending through the lumen of the housing;

At least one support member (e.g., a core wire) extending through the lumen of the housing in which at least the first joint and the second joint are located, the first joint joining the first portion of the housing to the support member, The two joints comprise the at least one support member joining the first portion of the housing to the second portion of the housing and the support member.

In another embodiment, the invention is a proximal assembly of a light guide wire,

A first tube (e.g., a hypotube) having a lumen extending through the first tube;

A long flexible housing (e.g., a cable conduit) having a lumen extending through the elongate flexible housing, the elongate flexible housing having a lumen extending through the elongate flexible housing, A flexible housing;

A second tube having a lumen through the second tube and located within the lumen of the first tube at the proximal end and extending beyond the proximal end of the first tube, Said second tube not extending beyond the end;

At least one illuminating fiber extending through the lumen of the housing and the lumen of the first tube and into the lumen of the housing and proximally beyond the lumen of the first tube and into the lumen of the second tube,

The housing is free to rotate in the first tube without being fixedly attached to the first tube and the distal end of the second tube and the proximal end of the first tube being fixedly attached.

Yet another embodiment is a connector, configured to receive an illuminated guide wire having an outer diameter,

Proximal portion,

Distal portion, and

And includes a bore extending through the proximal and distal portions and having a diameter less than the diameter of the outer diameter of the illuminated guidewire at a proximal portion (e.g., an aperture).

In a specific embodiment of the lighting device, the distal portion comprises a coil and the proximal portion comprises a cable tube. One or more illuminating fibers extend in the longitudinal direction within the proximal and distal portions and the distal end of such illuminating fibers is attached within the coil and proximal end. The core wire and the stranded wire are also configured within certain portions of the proximal and distal portions. Various approaches for accommodating illumination fibers within the profile of the connector and core wire are considered as relative motion between the attachment point and the component.

Other specific embodiments include the design of the proximal end of the illumination device connected to the light source via a removable connector that is connected to the optical cable of the light source after receiving the illuminated device, and certain features of the detachable connector are contemplated.

In a specific embodiment of the lighting device with the end connector, the distal portion comprises a coil and the proximal portion comprises a cable tube. One or more illuminating fibers extend in the longitudinal direction within the proximal and distal portions, the distal end of which is attached within the coil and the proximal end is received within the connector. The core wire is also constructed within the proximal and distal portions. Various approaches for accommodating illumination fibers within the profile of the connector and core wire are considered as relative motion between the attachment point and the component. Also, various embodiments of the connector are contemplated.

In addition, an approach for compensating for the varying length of the illuminating fiber is considered as an approach to facilitate the operation of the illumination device. In this regard, a structure may be included in the illuminator to accommodate changes in length, or steps may be taken to process the illuminated fibers to control the length variation. Drugs can also be injected into the intervention site to aid the lighting process.

A method for visually confirming positioning of a distal end portion of a device disposed within a patient includes inserting a distal end portion of the illumination device into the patient; Emitting light from a distal end portion of the illumination device; Observing transmission illumination emerging from the light emitted from the distal end portion of the illumination device, which is expressed on the exterior surface of the patient; And correlating the position of the observed transmitted illumination on the patient's exterior surface with the internal position of the patient below the location of the observed transmission illumination, to confirm positioning of the distal end portion of the illumination device.

In at least one embodiment, observation is performed by human observation of a direct line of sight without the need for fluoroscopy.

In at least one embodiment, the observation is performed by human observation of a direct gaze without the need for any visualization equipment.

In at least one embodiment, the illumination device includes a guide wire.

In at least one embodiment, the illumination device includes a papermaker device.

In at least one embodiment, the illumination device includes a sinusoidal suction device.

In at least one embodiment, the illumination device includes an integral wire expanding catheter wherein the integral illumination guide wire extends in a distal direction from a distal end of the expansion catheter.

In at least one embodiment, the distal end portion of the illumination guide wire is inserted into the patient ' s sinus passage.

In at least one embodiment, the distal end portion of the illumination guide wire is inserted through the pore opening into the patient ' s sinus, and the distal end portion is advanced into the sinus.

In at least one embodiment, the distal end portion of the illumination guide wire is initially inserted through the patient ' s nostril and then advanced into the sinus.

In at least one embodiment, the scope is inserted through the patient ' s nostril, where the guide wire is inserted adjacent to the scope, and advancement of the distal end portion of the guide wire is performed when the distal end portion is advanced towards the pores of the sinus Scope.

In at least one embodiment, the transmission illumination is observed when the light emitting portion of the distal end portion is located in the patient ' s sinus.

If the transmission illumination and the observation of the correlation indicate that the distal end portion of the illuminator has advanced to a wrong path to a position other than the target position, then the distal end portion of the apparatus may be retracted and proceed to a new path to the target position, Can be confirmed by observing the correlation.

When observing transmission illumination, when the distal end portion is moved relative to the patient, the movement of the transmitted illumination point resulting from the light emitted from the distal end portion of the illuminator may be visually observed and tracked or followed, It can be one way of confirming that the transmission illumination point is correlated to the position of the distal end portion. This technique may be particularly useful when there is an additional source of transmission light, for example light from the scope.

Further, the transmitted illumination resulting from the light emitted from the distal end portion of the device is generated from the light emitted from the scope by identifying the transmitted illumination point, which is at least one of brighter, smaller or more distinct than other observed transmitted illumination effects Lt; RTI ID = 0.0 > illumination. ≪ / RTI > Alternatively, the transmission illumination resulting from the light emitted from the distal end portion of the device can be distinguished from the transmission illumination resulting from light emitted from the scope by turning off or weakening the light source to the scope.

In at least one embodiment, the sinus guide is inserted into the patient prior to inserting the device, and the distal end portion of the illuminator is inserted through the sinus guide.

In at least one embodiment, the illumination device is preloaded within the guide, and the guide and preloaded illumination device are inserted together into the patient. Advancement of the illumination device to the guide can then be performed to extend the distal end portion of the illumination device in a distal direction from the distal end of the guide.

The scope can be inserted into the patient, where the sinus guide is inserted adjacent to the scope, and the advancement of the sinus guide can be visualized through the scope.

In at least one embodiment, the visualization of the advancement of the sinus guide is achieved through the use of a scope, up to the limit of adequate illumination by the scope. The light emitted by the distal end portion of the illuminator, advanced in the distal direction from the distal end of the sinus guide, then extends the appropriate illumination limit of the scope, thereby extending the length of the appropriate illumination of the scope.

In at least one embodiment, the sinus guide may be advanced further distally under visualization by the scope as facilitated by the extended length of the appropriate illumination.

In at least one embodiment, visualization of advancement of the illumination device in the distal direction from the sinus guide may be performed through the scope, as facilitated by light emitted from the distal end portion of the device.

In at least one embodiment, the scope is inserted into the patient's nostril, and the sinus guide is inserted adjacent to the scope.

In at least one embodiment, the scope and the sinus guide are advanced into the patient ' s sinus passage.

In at least one embodiment, the sinus guide is advanced further toward the pores of the sinus, and the advancement of the sinus guide is visually observed through the scope.

In at least one embodiment, the scope is inserted into the patient's nostril, and the sinus guide is inserted adjacent to the scope. Advancement of the sinus guide into the sinus passageway is visualized through the scope until the distal end of the sinus guide reaches the distal limit of the illumination emitted by the scope.

In at least one embodiment, the further advancement of the sinus guide towards the pores of the sinus is visualized through the scope as facilitated by the extended length of the appropriate illumination provided by the illumination device.

In at least one embodiment, the scope is inserted into the patient's nostril, and the sinus guide is inserted adjacent to the scope. Advancement of the sinus guide to place the distal end of the sinus guide adjacent to the entrance of the sinus of the sinus is visualized through the scope.

In at least one embodiment, the distal end portion of the illuminator is advanced distally from the distal end of the sinus guide and further away from the limit of illumination of the scope for emitting illumination, so that the space can be visualized by the scope .

In at least one embodiment, the distal end portion of the device is advanced further into the pores and further through the pores, and visualization of the advancement of the distal end portion into the pores is performed through the scope.

In at least one embodiment, the device includes an illumination guide wire, and the operating device is advanced over the guide wire to place the operative end of the operating device in the target position, and the surgical procedure is performed on the operating device at the target position. The actuating device is removed from the patient after performing the surgical procedure. Alternatively, the implant may be left at the target position.

CLAIMS What is claimed is: 1. A method of performing a minimally invasive surgical procedure comprising: inserting a distal end portion of an illumination guide wire into a patient; Emitting light from a distal end portion of the illumination guide wire, the proximal end portion being connected to a power source to allow the distal end portion to emit light; Observing the transmitted illumination emerging from the light emitted from the distal end portion of the illumination guide wire, which is expressed on the external surface of the patient; Correlating the position of the observed transmitted illumination on the patient ' s external surface with the internal position of the patient below the position of the observed transmitted illumination, to confirm positioning of the distal end portion of the illumination guide wire; Separating the proximal end portion of the illumination guide wire from the power source; Advancing the actuating device over the guide wire such that a proximal end of the guidewire extends proximally from the actuating device; Reconnecting the proximal end portion of the illumination guide wire to the power source such that the distal end portion of the guide wire again emits light; Positioning an operating end of the operating device at a target position; And performing a surgical procedure from the target position to the operating device.

After performing the surgical procedure, the proximal end portion of the illumination guide wire is separated from the power source; The actuating device is removed from the patient and from the guide wire. Alternatively, the implant may be left at the target position.

In at least one embodiment, the second actuating device is advanced over the guidewire after removing the first actuating device from the guidewire such that the proximal end of the guidewire extends proximally from the second actuating device. The proximal end portion of the illumination guide wire is then reconnected to the power source such that the distal end portion of the guide wire again emits light.

In at least one embodiment, the illumination guide wire includes at least one illumination fiber extending from the proximal end to the distal end portion of the guide wire, and the power source is a light source.

In at least one embodiment, the illumination guide wire includes at least one laser fiber extending from the proximal end to the distal end portion of the guide wire, and the power source is a laser light source.

In at least one embodiment, the illumination guide wire includes a wire that electrically connects the light emitting diode to the power source, the power source extending through the light emitting diode and the guide wire of the distal end portion, wherein the power source is a power source.

A method for diagnosing and / or treating sinusitis in an animal or human patient or other disease occurring in the nose, sinus or other anatomical structures of the ear, nose or throat, comprising the steps of: Advancing to a position near the opening of the sinus; Advancing a distal end portion of the illuminator that emits light from the distal end portion through the introducer while the proximal end of the illuminator is connected to the power source; And monitoring the position of the distal end portion of the distal end illumination device at the distal end of the introducer device by observing the transmitted illumination on the patient ' s outer surface resulting from the light emitted by the distal end portion . The emitted light may be the desired wavelength in the visible spectrum and / or the infrared spectrum.

In at least one embodiment, the distal end portion of the illumination device is advanced through the opening of the sinus; The placement of the distal end portion of the illumination device within the sinus can be accomplished by observing the transmitted illumination emerging from the light emitted from the distal end portion of the illumination device, which is expressed on the external surface of the patient, By correlating the position with the internal position of the patient below the position of the observed transmission illumination.

In at least one embodiment, the outer surface over which the transmission illumination is viewed is on the patient ' s face.

In at least one embodiment, the outer surface over which the transmission illumination is viewed lies on the patient ' s palate.

In at least one embodiment, the illumination device includes an illumination guide wire, and an actuating device is provided that is operable to perform a diagnostic or therapeutic procedure where it can be placed in a surgical position. The proximal end of the illumination guide wire is separated from the power source while maintaining the distal end portion of the illumination guide wire in its current position and the actuating device is advanced over the guide wire such that the proximal end of the guide wire extends proximally from the actuating device. The proximal end of the illumination guide wire is then reconnected to the power source such that the distal end of the guide wire again emits light. The actuating device is further advanced to a position in which the operative end of the actuating device is in the operative position and a diagnostic or therapeutic procedure is performed on the actuating device in the operative position.

In at least one embodiment, the operative position is an opening to the sinus.

An illumination guide wire apparatus, comprising: a flexible distal end portion; A relatively smaller proximal end portion of flexibility; At least one light-emitting element within the distal end portion; And at least one structure extending through at least a portion of the proximal end portion and the distal end portion from the proximal end of the device for connecting the at least one light emitting element with a power source located in proximity to the device / RTI >

In at least one embodiment, the at least one light emitting element comprises a distal end of at least one illuminating fiber, and at least one of the at least one structure comprises at least one light source extending from the distal end of the fiber in a proximal direction to the proximal end of the device Fiber.

In at least one embodiment, the power source is a light source.

In at least one embodiment, at least one light emitting element of the illumination guide wire comprises a distal end of the at least one laser fiber, and at least one structure extends from the distal end of the fiber in a proximal direction to the proximal end of the device At least one laser fiber.

In at least one embodiment, the power source is a laser light source.

In at least one embodiment, the at least one light emitting element comprises a light emitting diode, and at least one structure comprises at least one wire electrically connected to the light emitting diode and extending from the light emitting diode in a proximal direction to the proximal end of the device, .

In at least one embodiment, the power source is a power source.

In at least one embodiment, the distal end portion of the guide wire has an outer diameter that is configured and dimensioned to pass through the pores of the sinus.

In at least one embodiment, the distal end portion of the guide wire has an outer diameter of less than about 0.965 mm (0.038 inches).

In at least one embodiment, the distal end portion of the guide wire has an outer diameter of about 0.835 mm (0.0035 inch). In at least one embodiment, the illumination guide wire is about 0.038 mm (0.038 inch) ). ≪ / RTI >

In at least one embodiment, the illumination guide wire has a maximum outer diameter of less than about 0.835 mm (0.035 inch).

In at least one embodiment, the illumination guide wire has a maximum outer diameter of about 0.835 mm (0.0035 ") < RTI ID = 0.0 >

In at least one embodiment, the distal end portion of the device comprises a flexible coil. In at least one embodiment, the distal end portion also includes a core wire extending into the interior of the coil. In at least one embodiment, the core wire is secured to the coil.

In at least one embodiment, the core wire extends within the distal end portion and the proximal end portion of the device. In at least one embodiment, the core wire extends substantially within the entire length of the distal and proximal end portions.

In at least one embodiment, the distal end portion of the device includes a bend such that the proximal portion of the distal end portion is substantially aligned with the longitudinal axis of the device and the distal portion of the distal end portion is bent relative to the longitudinal axis.

In at least one embodiment, the distal end of the at least one illuminating fiber is configured to emit light from the distal tip of the distal end portion of the device. The distal tip may be designed to focus or distribute light to achieve maximum transmission illumination. The distal tip may include a lens, a prism, or a diffractive element.

In at least one embodiment, the distal end of the at least one illumination fiber is positioned proximal of the distal tip of the distal end portion of the device.

In at least one embodiment, the flexible distal portion of the distal end portion extends in a distal direction from the distal end of the at least one illuminating fiber.

In at least one embodiment, the distal end of the at least one laser fiber is configured to emit light from a distal tip of the distal end portion of the device.

In at least one embodiment, the distal end of the at least one laser fiber is located proximal to the distal tip of the distal end portion of the device.

In at least one embodiment, the flexible distal portion of the distal end portion extends in a distal direction from the distal end of the at least one illuminating fiber.

In at least one embodiment, the light emitting diode is mounted on the distal tip of the distal end portion of the device.

In at least one embodiment, the light emitting diode is positioned proximal of the distal tip of the distal end portion of the device. In at least one embodiment, the flexible distal portion of the distal end portion extends in a distal direction from the light emitting diode.

In at least one embodiment, the power source is removably electrically connected to the at least one structure to provide power to the at least one light emitting element.

In at least one embodiment, at least one light conducting tube conveys light from the proximal end portion of the device to the distal end of the tube, where light is emitted.

In at least one embodiment, each light conducting tube is sealed at the proximal end of the device.

In at least one embodiment, each light emitting element is sealed at the distal tip of the device.

In at least one embodiment, the quick release connector is mounted on at least a portion of the proximal end portion of the guide wire. The quick release connector is configured to be connected to the power source and to be quickly connected to and released from the proximal end portion of the guide wire.

In at least one embodiment, the quick release connector is optically coupled to a light source.

In at least one embodiment, the proximal end portion of the quick release connector is configured to be coupled to a light source.

In at least one embodiment, the proximal end portion of the quick release connector includes an ACMI Corporation light post.

In at least one embodiment, the connector is rotatable about a light channel extending from the light source when the connector is connected to the optical channel. In at least one embodiment, the optical cable comprises a fluid filled optical cable.

In at least one embodiment, the distal end portion of the connector includes an opening configured to slidably receive a proximal end portion of the guidewire device, wherein the quick release locking mechanism is configured to secure a proximal end portion received within the connector do.

In at least one embodiment, the quick release locking mechanism is movable between a non-locked configuration in which the proximal end portion can be slid therefrom for detachment from the connector and a locked configuration for retaining the proximal end portion in connection with the connector Do. In at least one embodiment, the quick release locking mechanism is biased toward the locked configuration.

In at least one embodiment, a radiopaque marker is provided on the distal end portion of the guide wire.

In at least one embodiment, an electromagnetic coil is provided at the distal end portion of the guide wire. Alternatively, a magnet, high frequency emitter or ultrasonic crystal may be provided at the distal end portion of the guide wire.

An illumination device comprising: a distal end portion having an outer diameter configured and dimensioned to pass through a pore of a sinus; at least one light-emitting element within a distal end portion; and a proximal end portion of the device for connecting the at least one light- And at least one structure extending through at least a portion of the proximal end portion and the distal end portion.

In at least one embodiment, the illumination device includes an illumination guide wire.

In at least one embodiment, the illumination device comprises a papermaking device and the distal end portion is rigid or malleable.

In at least one embodiment, the illumination device includes a pore-seeker device, wherein the distal end portion includes a ball tip at a distal end thereof.

In at least one embodiment, the illumination device includes a sinus suction device and the distal end portion also includes an aspiration lumen configured and adapted to apply a suction force therethrough.

In at least one embodiment, the illumination device includes an integral wire expanding catheter wherein the integral illumination guide wire extends in a distal direction from a distal end of the expansion catheter of the device.

An illumination guide wire apparatus, comprising: a long body having a flexible distal end portion and a relatively smaller flexible proximal end portion; An illumination comprising at least one light conducting channel configured to extend the length of the elongated body and to transmit light from the proximal end of the guidewire to the distal end of the guidewire and to be configured and dimensioned to emit light from the distal end of the guidewire A guide wire device is provided.

In at least one embodiment, the at least one light conducting channel comprises at least one illuminating fiber.

In at least one embodiment, the at least one light conducting channel comprises at least two illuminating fibers.

In at least one embodiment, the illuminating fibers are formed of plastic.

In at least one embodiment, the at least one illuminating fiber is formed of glass.

In at least one embodiment, the at least one light conducting channel comprises at least one laser fiber.

In at least one embodiment, the quick release connector is mounted on at least a portion of the proximal end portion of the elongate body, is configured to be connected to the optical channel extending from the source and to be quickly connected to and released from the proximal end portion of the elongate body. do.

In at least one embodiment, the quick release connector is optically coupled to a light source.

In at least one embodiment, the proximal end portion of the connector includes a tapered optical channel configured to fit a relatively larger inner diameter of the optical channel to a relatively smaller diameter of the proximal end of the elongate body.

In at least one embodiment, the proximal end portion of the quick release connector is configured to be coupled to the light source. In at least one embodiment, the proximal end portion of the quick release connector includes an AAC light post.

In at least one embodiment, the connector is rotatable about a light channel extending from the light source when the connector is connected to the optical channel.

In at least one embodiment, the distal end portion of the connector includes an opening configured to slidably receive a proximal end portion of the elongate body, wherein the quick release locking mechanism is configured to secure a proximal end portion received within the connector .

In at least one embodiment, the quick release locking mechanism maintains the proximal end of the elongate body in alignment with the distal end of the tapered optical channel of the connector, in a locked configuration.

In at least one embodiment, the quick release locking mechanism is movable between a non-locked configuration in which the proximal end portion can be slid therefrom for detachment from the connector and a locked configuration for retaining the proximal end portion in connection with the connector Do.

In at least one embodiment, the core wire extends at least within the distal end portion of the elongate body of the guide wire. In at least one embodiment, the core wire also extends within the proximal end portion.

An illumination guide wire apparatus, comprising: a guide wire having an elongate body having a flexible distal end portion and a relatively smaller, proximal end portion; A light emitting diode mounted within the distal end portion and configured to emit light from a distal tip of the distal end portion; And at least one wire extending in the proximal direction from the proximal end of the elongate body, the elongate body extending in length and electrically connected to the light emitting diode.

In at least one embodiment, the illumination guide wire includes at least two such wires.

In at least one embodiment, the core wire extends within at least the distal end portion of the elongate body. In at least one embodiment, the core wire also extends within the proximal end portion.

In at least one embodiment, a radiopaque marker is provided on the distal end portion. In at least one embodiment, an electromagnetic coil is provided on the distal end portion.

An illumination guide wire device, comprising: a guide wire having a flexible distal end portion, a relatively smaller flexible proximal end portion, and a transparent portion interconnecting the distal and proximal end portions; At least one light emitting element mounted within the guide wire and configured to emit light through the transparent portion; And at least one structure extending from the proximal end of the device through the proximal end portion and connected to the at least one light emitting element.

In at least one embodiment, the transparent portion comprises a transparent tube.

In at least one embodiment, the transparent tube includes a notch window therein.

In at least one embodiment, the transparent portion includes a plurality of struts interconnecting the proximal and distal end portions of the guide wire.

In at least one embodiment, the deflector is mounted on a circle of at least one light emitting element within the transparent portion.

In at least one embodiment, the quick release connector is configured to be mounted on at least a portion of the proximal end portion, to be connected to the optical channel extending from the light source, and to be quickly connected to and released from the proximal end portion of the guide wire.

In at least one embodiment, the core wire extends at least within the distal end portion. In at least one embodiment, the core wire also extends within the proximal end portion.

A quick release connector for use with an illumination guide, comprising: a body having a proximal end portion and a distal end portion; A channel within a distal end portion and open at a distal end of the body, the channel configured and dimensioned to slidably receive a proximal end portion of the illumination guide wire; And a quick release locking mechanism configured to take the locked position and the non-locked position, wherein the quick release locking mechanism fixes the proximal end portion of the illumination guide wire within the channel in the locked position.

In at least one embodiment, the quick release locking mechanism is biased to the locked position.

In at least one embodiment, upon insertion of the proximal end portion of the illumination guide wire into the channel, the proximal end portion is in contact with the portion of the quick release locking mechanism to allow the proximal end portion to fall into the channel Force.

In at least one embodiment, the quick release locking mechanism includes a locking arm extending into the channel and a portion extending out of the housing, wherein the portion extending out of the housing moves the locking arm from the locked position to the non-locked position It is possible to retreat manually.

In at least one embodiment, the quick release locking mechanism includes at least two locking arms provided circumferentially around the distal end portion of the body of the connector.

In at least one embodiment, the quick release locking mechanism includes a pin vise.

In at least one embodiment, the proximal end portion of the connector is configured to be coupled to a light channel extending from the light source.

In at least one embodiment, the proximal end portion of the body is optically coupled to the light source.

In at least one embodiment, the proximal end portion of the body includes a tapered optical channel configured to fit a relatively larger inner diameter of the optical channel to a relatively smaller diameter of the proximal end of the illumination guide wire.

In at least one embodiment, the proximal end portion of the body includes an AAC light post.

In at least one embodiment, the quick release connector is rotatable relative to a light channel extending from the light source when the connector is connected to the optical channel.

These and other advantages and features of the present invention will become apparent to those skilled in the art upon reading the details of the apparatus, method and system as described more fully below.

Other features and advantages will become apparent from the following detailed description taken in conjunction with the accompanying drawings, which illustrate, by way of example, the features of various embodiments.

≪ 1 >
BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows a patient treated by a system for catheter-based minimally invasive sinus surgery according to the prior art.
2A to 2D,
Figures 2a-2d illustrate partial sagittal cross-sectional views through the human head showing various stages of a method of approaching a sinus using a sinus guide.
3,
3 is a view showing a scope introduced into the sinusoidal guide side;
<Fig. 4>
4 illustrates a lighting guide wire according to an embodiment of the present invention.
5,
5 shows a distal end portion of a guide wire having a bent shape;
6,
6 is a cross-sectional view of a distal end portion of a guidewire device showing a core wire secured to a coil;
7,
7 is a cross-sectional view of a guide wire device including an optical fiber bundle of optical fibers.
8,
8 is a view showing a light guide wire according to another embodiment of the present invention;
9,
Figure 9 is a cross-sectional view of the distal end portion of the guide wire shown in Figure 8;
<Fig. 10>
10 is a view showing an illumination guide wire according to another embodiment of the present invention;
11)
Figure 11 illustrates an alternative transparent portion that may be included in the apparatus shown in Figure 10;
12,
12 illustrates another alternative transparent portion that may be included in the apparatus shown in FIG. 10; FIG.
13A)
13A illustrates a light guide wire device including a quick release connector optically coupled to a light source;
13 (b)
13B is a view of the apparatus of FIG. 13A in which the quick release locking mechanism is in the locked position.
14A and 14B,
Figure 14A illustrates an alternative quick release connector;
14B,
14B illustrates the connector of FIG. 14A mounted over the proximal end portion of the illumination guide wire. FIG.
<Fig. 15>
Figure 15 illustrates another alternative quick release connector;
<Fig. 16>
Figure 16 illustrates another alternative quick release connector;
<Figs. 17A to 17E>
Figures 17a-17e are partial cross-sectional views through the human head showing the various steps of the method for treating the pores opening into the frontal opening.
18,
Figure 18 illustrates a situation similar to that shown with respect to Figure 3, wherein the scope is inserted as far as possible without causing significant trauma to the patient. In addition, FIG. 18 shows that the illumination guide wire extends in the distal direction from the illumination limit of the scope, in order to effectively extend the illumination distance observable by the scope.
19,
19 illustrates a non-limiting example in which one or more filters can be placed in an illumination guidewire device;
20A,
20A is a view schematically showing a connector in which a rotary shutter is rotatably mounted therein.
20B,
FIG. 20B is a plan view of the shutter of FIG. 20A. FIG.
21,
21 shows a frontal opening papilla navigator device that can be used to access a sinusoidal pore.
22,
22 illustrates a suction sinusoidal mechanism configured to drain blood and / or other fluid from a target surgical site, such as a frontal sinus.
23,
23 illustrates an integral wire expanding catheter 120 that includes an elongate flexible catheter shaft on which the balloon is mounted.
<Fig. 24>
24 is a view showing another embodiment of the illumination guide wire of a predetermined length;
25,
25 is a sectional view of the illumination guide wire of Fig.
26,
26 is a cross-sectional view of a preferred cable duct;
<Fig. 27>
27 is a view showing another embodiment of a core wire;
28,
28 is a view showing still another embodiment of a core wire;
29,
29 is a cross-sectional enlarged view of the assembly shown in Fig. 25;
30,
30 is a cross-sectional view of another approach for securing a core wire within a cable conduit;
31,
31 illustrates yet another approach to constructing a core wire in a cable conduit;
<Fig. 32>
32 illustrates the exterior of a connection assembly;
33,
33 illustrates a cross-section of the connector assembly of FIG. 32;
34,
34 is a cross-sectional view of an alternative connector assembly.
<Fig. 35>
35 is a cross-sectional view of another embodiment of a connector assembly;
<Fig. 36>
Figure 36 is a side cross-sectional view of the connector assembly of Figure 35;
37,
37 is a view showing an illumination guide wire according to an embodiment of the present invention;
37Aa <
37A shows a section of the guide wire of FIG. 37 at point AA within the distal coil region; FIG.
<Fig. 37bb>
37B shows a section of the guide wire of FIG. 37 at point BB in the proximal coil region; FIG.
<37 cc>
Figure 37cc shows a cross-section of the guide wire of Figure 37 at point CC in the distal cable tube region;
37D,
Figure 37d shows a section of the guide wire of Figure 37 at point DD in the proximal cable tube area;
<37ee>
Figure 37ee shows a section of the guide wire of Figure 37 at point EE in the distal hypotube region;
37ff)
37ff shows a section of the guide wire of Fig. 37 at point FF in the proximal hypotube region; Fig.
38,
38 is a sectional view of the illuminated guide wire of FIG. 37;
38A)
FIG. 38A is a detailed view of an area A of the guide wire in FIG. 38; FIG.
38B,
FIG. 38B is a detailed view of a region B of the guide wire of FIG. 38; FIG.
38C,
38C is a detailed view of an area C of the guide wire in FIG.
39,
39 is a cross-sectional view of an alternative connector assembly.
39A)
39A is a detailed view of the proximal end portion of the connector of Fig.

The present invention provides an apparatus and method for eliminating or reducing the need for remote imaging techniques. To achieve this, a medical device is disclosed having desirable indentability and torque transfer to reach the intervening region. The disclosed medical device includes a component that implements a structure or that is preprocessed to accommodate the force applied to it during surgery.

Before the apparatus and method of the present invention is described, it should be understood that the present invention is not limited to the specific embodiments described, and can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, as the scope of the invention is to be limited only by the terms of the appended claims.

Where a range of values is provided, each intervening value between the upper and lower limits of the range shall be understood to be specifically disclosed to the tenth of the 1 digit of the lower limit unless the context clearly dictates otherwise do. Each smaller value range between any recited value or intervening value within the recited range and any other recited or intervened value within such recited range is encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included within or excluded from the range, and each range in which either or both limits are included within a smaller range or which are neither included in a smaller range Quot; is &lt; / RTI &gt; also included within the present invention subject to any specifically excluded limit within the range. In the case where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the present invention.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in which publications are cited in connection.

It should be noted that, as used in this specification and the appended claims, the singular forms (amorphous and definite) include a plurality of referents unless the context clearly dictates otherwise. Thus, for example, reference to " one tube " includes a plurality of such tubes, and reference to " shaft " includes reference to one or more of the shafts and equivalents thereof known to those skilled in the art .

The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present invention is not entitled to antedate such publication by a prior invention. Also, the date of the publication provided may be different from the actual publication date, which may need to be independently verified.

Referring now to FIG. 1, there is shown a view of a patient being treated by a system for catheter-based minimally invasive sinus surgery according to the prior art. A second introducer device 1004 (e.g., a guidewire or elongate probe) and an actuation device 1006 (e.g., a balloon catheter, other extension device) 1006 (e.g., C-arm fluoroscope (1000), which can be used to visualize a catheter, a dilator, a cutter, and the like. The sinus guide, guide catheter, or guide tube 1002 may be used for direct visualization, visualization provided by the fluoroscopic vision system 1000, and / or the like provided for placement of the distal end of the catheter or tube 1002 proximate to the pores of the sinuses to be treated. Or under endoscopic visualization.

A guidewire or long probe 1004 is then inserted through the catheter or tube 1002 and the distal end of the guidewire or elongate probe is passed through the pore to be treated in the distal direction to extend into the sinus opening into the pore It is advanced. The correct placement will often be such that the distal end of the guidewire or elongate probe will remain visible under fluoroscopic visualization until the surgeon is visually confirmed to be located where it believes that the proper sinus is located, Lt; RTI ID = 0.0 &gt; retraction &lt; / RTI &gt; of the distal end of the guidewire or elongate probe.

When the guide wire or long probe 1004 is correctly positioned, the actuating device 1006 then moves the operating end of the actuating device 1006 to the position of the fluoroscopic vision instrument 1000 and / Or over a guidewire or long probe 1004 under visualization through an endoscope (not shown) inserted adjacent to the catheter or tube 1002. Typically, the guide wire or long probe is held in place during the procedure. Under the visualization of the same type (s), the operating (distal) end of the operating device is then operated to perform the desired surgical procedure. In the case of an expanding catheter, the balloon at the distal end portion of the catheter 1006 is expanded once it is positioned across the pore. This expansion serves to open the pores and allow an appropriate mucus flow, as described in more detail above.

After performing the desired surgical procedure, the operating device 1006 is stopped and withdrawn from the patient, after which the remaining device is withdrawn to complete the procedure.

By using the apparatus and method described herein, the need for fluoroscopic visualization of at least a guidewire / long probe placement can be reduced or eliminated. Also optionally, the need for all fluoroscopic visualization can be eliminated in some surgical settings.

It should be appreciated that the apparatus and method of the present invention is directed to accessing and expanding or deforming the sinus ostium or other passageways in the ear, nose, and throat. These devices and methods may be used alone or in combination with other surgical or non-surgical procedures, including but not limited to delivery or implantation of devices and drugs or other materials as described in co-pending U.S. Patent Application No. 10 / 912,578, It can be used with surgical treatment.

Figures 2a-2d are partial sagittal cross-sectional views through the human head showing various stages of a method of approaching the sinus using a sinus guide. In Figure 2a, a first introducer in the form of a sinus guide 1002 is introduced through a nostril and through the nasal cavity 1012 to a location proximate the pores 1014 of the sphenoid 1016. The sinus guide 1002 can be straight, malleable, or it can be, for example, disclosed in U.S. Patent Nos. 2006/004323; 2006/0063973; And 2006/0095066, each of which is incorporated herein by reference in its entirety. &Lt; RTI ID = 0.0 &gt; [0002] &lt; / RTI &gt; In an embodiment in which the sinus guide 1002 is curved or bent, the deflection angle of the curved or bent portion may be within a range of up to about 135 degrees.

2B, a second introduction device including a guide wire 10 guides the distal end portion of the guide wire 10 to the first introduction device (i.e., the sinus guide 1014) 1002).

In FIG. 2C, an actuating device 1006, such as a balloon catheter, is introduced over the guide wire 10 and advanced to extend the distal end portion of the device 1006 into the sphenoid 1016. Thereafter, in Fig. 2d, the actuation device 1006 is used to perform a diagnostic or therapeutic procedure. In this particular example, the procedure is an extension of the sphenoid small hole 1014, as shown in Figure 2D, where the balloon of the device 1006 expands to expand the opening of the pore 1014. After the completion of the procedure, the sinus guide 1002, the guide wire 10, and the operating device 1006 are pulled out and removed. It will be appreciated that the present invention can also be used to expand or modify any sinus pores or nose, sinus, nasopharynx or other artificial or naturally occurring anatomical openings or passageways in adjacent areas. As will also be appreciated by those skilled in the art, in this or any of the procedures described in this patent application, the operator can further advance other types of catheters, and the guide wire 10 can be steered (e.g., Actively deformable) or may be configurable or malleable.

Figures 2B-2D illustrate a side view of a surgical instrument 1006 that may be inserted and / or inserted with the catheter 1006 to provide visualization of the advancement of the sinus guide 1002, An optional scope 1008 is shown in phantom. As described further in Provisional Application No. 60 / 844,874 (Attorney Docket No. ACCL-003PRV) entitled " Endoscopic Methods and Devices for Transnasal Procedures ", an optional scope 1008 may comprise any suitable type of rigid or flexible scope and such selective scope may be separate or included with the actuating device and / or introducing device of the present invention, Incorporated herein by reference in its entirety.

Scope 1008 may be useful to reduce or eliminate the need for fluoroscopic visualization during placement of sinus guide 1002 and / or the need for visualization of the procedure performed by actuation device 1006, (E.g., the sphenoid 1016 or other sinuses in which it is of interest), and thus can be used to guide the guide wire 10 into the desired sinus (e. G. Frontal sinus or any other sinus of interest) Sufficient visual feedback or sufficient visual image confirmation of the correct placement of the guide wire 10 into the desired sinus can not be provided.

In addition, depending on the particular configuration of the sinus passage to be sacrificed to approach the target pore, the scope 1008 may not be as deeply visible as the location of the pore of interest due to physical constraints (e.g., outer diameter, stiffness, etc.). For example, Figure 3 illustrates a situation in which scope 1008 is inserted as far as possible without causing significant trauma to the patient. In this case, the range of the appropriately illuminated clock does not extend all the way to the pores 1020, as schematically indicated by the ray 1009 shown extending from the scope 1008 in the distal direction. In such a case, a properly illuminated visualization of the guide wire 10 into the pore 1020 would not be possible via the scope 1008. [ Also, if the sinus guide 1002 can be extended farther physically in the distal direction to place its distal end at the inlet of the pore 1020, then the scope 1008 will also not be able to properly visualize it. Thus, prior to the present invention, the fluoroscopic or X-ray visualization of these procedures, in order to ensure that the device is approaching (and extending through) the appropriate pores 1020 rather than other adjacent openings, such as openings 1024, .

To overcome these and other problems, the guidewire device 10 of the present invention includes its own light emitting capability. By illuminating the distal end portion of the guide wire 10, a process known as transmission illumination occurs when the guide wire 10 traverses the sinus passages, passes through the pores, and enters the sinus cavity. Transmitted illumination refers to the passage of light through a body part or a wall of an organ. Thus, when the guide wire 10 is positioned in the sinus, the light emitted from the guide wire 10 passes through the facial structure and appears as a shiny area on the patient's skin (e.g., facial). It should be noted that, for example, light emitted from the scope 1008 as shown in FIG. 3 also causes transmission illumination, but the generated light is much more diffused and larger in area. The closer the light source in the guide wire 10 is to the surface of the structure (e.g., the surface of the sinus) into which it is inserted, the brighter and more focused the transmission light effect (i. E. Also, the movement of the guide wire 10 can be tracked by following the movement of the transmitted illumination point created on the skin of the patient. These concepts are described in co-pending U.S. Patent Application No. 12 / 122,884 and U.S. Patent No. 7,559,925 entitled "Sinus Illumination Lightwire Device", the entirety of which is hereby incorporated by reference herein in its entirety Which is incorporated herein by reference.

Figure 4 shows a light guide wire 10 according to one embodiment of the present invention. It includes a flexible distal end portion (10 d) to provide a softness similar to the guide wire of the lighting type-device 10 is non-standard. Distal end portion (10 d) may comprise a coil (10 c) as its outer portion to aid in providing the flexibility desired for this part properties. The proximal end portion 10p of the device 10 is configured such that the device 10 is positioned in the proximal direction outside the patient (including the deepest location where the distal end of the device 10 is located) (In the proximal direction outwardly of the device into which the guide wire 10 is inserted). The proximal end portion 10p may have a visible marking, preferably equidistantly spaced, that can be observed by a user to ascertain to what extent the guide wire 10 has been placed in the patient. The proximal end portion 10p also provides the required mechanical properties required to properly perform the guide wire function. These mechanical properties are the ability to apply a torque to the proximal end portion (10 p) from the position before the torque achieved, that is outside the patient, and delivering the torque to the distal end portion (10 d); Press-in ease of use, i.e. when the make an operator to push the proximal end portion (10 p) from a location outside of the patient, pressing force to advance the distal portion (10 d) transfer the device 10 without buckling the distal portion (10 d) of the Sufficient stiffness to allow; And tensile strength that allows the operator to pull the proximal end portion 10p out of the patient's location and withdraw the device 10 from the patient without significant plastic deformation or any degradation of the device.

The coil 10c may be formed of, for example, a stainless steel wire. The diameter of the coil wire may be from about 0.102 mm to about 0.203 mm (0.004 to about 0.008 inch), typically about 0.152 mm (0.006 inch). An alternative material from which the coil 10c can be formed is ELGILOY TM, CONICHROME TM or other biocompatible cobalt-chromium-nickel alloy; Nickel-titanium alloys, or other known biocompatible metal alloys having similar properties. Alternatively, the distal end portion may comprise a braided metallic structure of any of the foregoing materials instead of a coil.

The outer casing of the proximal portion 10p includes a polyimide sheath, a continuous coil (optionally embedded in the polymer or laminated on top of the polymer), a hypotube (e.g., stainless steel hypotube), a laser- , Cable conduits, PEBAX (nylon resin) or other medical grade resins. In any of these cases, the configuration needs to meet the required torque transfer, ease of indentation and tensile requirements of the device.

In the example shown, the coil 10c is bonded to the proximal portion 10p by solder, epoxy or other adhesive or mechanical joint. One or more illumination channels 10i are provided in the apparatus 10 and extend along its length. Lighting Channel (10 i) is composed of the light to the distal end of the device 10 from the proximal end of the device 10 and to carry out his. In the example shown, two illumination channels are provided, each containing plastic illuminating fibers. The plastics used to make the illuminating fibers are blended for light transfer properties according to techniques known in the art and available in the art. As an example, ESKA (TM) (Mitsubishi Rayon) having a concentric two-layer structure with a thin layer of a high purity polymethyl methacrylate (PMMA) core and a specially selected transparent fluoropolymer cladding, high performance plastic optical fiber is used . In one example, each of the illumination fibers has an outer diameter of about 0.010 &quot; (0.010 &quot;). The illuminating fiber may have an outer diameter in the range of about 0.127 mm (0.005 inch) to about 0.254 mm (0.010 inch).

Alternatively, from about 0.508 ㎜ (0.020 ") single one trillion people plastic fiber (10 i) having an outer diameter of can be used. Alternatively, glass illumination fibers having a much smaller outer diameter, such as about 0.051 mm (0.002 &quot;), can be substituted. In such a case, there are more light fibers could be provided in a bundle, for example, be provided with about 6 to 50 glass fibers (10 i).

The distal end of the device 10 is sealed by a (one or semi-transparent) which may be in the form of a transparent epoxy or another transparent or translucent adhesive or sealing material seal (10 s). The seal (10 s) and is maintained to the distal end of the illumination fiber (10 i) that matches the distal end of the device 10, also it provides a non-traumatic tip of the device 10. In addition, the seal (10 s) will prevent the introduction of foreign matter into the apparatus. The distal end can be designed to focus or distribute light when light is emitted from it to achieve maximum transmission illumination effect. In this regard, the distal end may include a lens, a prism, or a diffractive element.

The proximal end of the device 10 is also sealed by a transparent (or translucent) seal 10 ps , which may also be in the form of an epoxy or other transparent or translucent adhesive or sealing material. The seal (10 ps ) keeps the proximal end of the illumination fiber 10 i coincident with the proximal end of the device 10. The proximal end of the device 10 may be further prepared by grinding and polishing to improve the optical properties at the interface of the light source and the proximal end of the device 10. [ One trillion people fiber (10 i) in the intermediate position between the proximal end and the distal end need not be fixed and typically does not fixed, because not only light is visible features, such as the system 10 provided by the endoscope The mapping of these fibers is not required. Further, the illuminated fibers are free to move from a position between the proximal end and a distal end, which is the overall flexibility and bendability of the device 10 relative to, and a similar device except that fixed inside the illumination fiber (10 i) .

The outer diameter of the device 10 may range from about 0.025 inch (0.025 inch) to about 1.016 mm (0.040 inch), typically about 0.762 to 0.965 mm (0.030 to 0.038 inch), and in at least one embodiment, 0.885 mm (0.035 &quot;) 0.127 mm (0.005 &quot;). At least the distal portion 10p of the device 10 is provided with a core wire 10cw received therein. In the example shown in Fig. 4, the core wire 10 cw is a wire secured to the proximal section 10 p by, for example, laser welding, epoxy or other adhesive or mechanical fastener. The core wire 10 cw may extend substantially along the entire length of the device 10. In either case, the core wire (10 cw ) is typically made of stainless steel NITINOL (nickel-titanium alloy) or other biocompatible nickel-titanium alloy, cobalt-chromium alloy, or biocompatible, The other metal alloy being provided. The core wire 10 cw may be formed as a wire as in the example shown in Fig. 4, or alternatively may be braided from any of the same materials or combinations of materials mentioned above. The core wire 10 cw can be ground to different diameters to provide varying amounts of stiffness and torque transfer when formed as a wire. When formed as a braid, the braid can be formed to have a positive amount of stiffness and torque transfer across its length. For example, the core wire 10 cw may have a larger outer diameter at the proximal end portion than at the distal end portion to deliver a greater torque from the proximal portion of the device 10, which is more rigid, while at the distal end portion, The core (10 cw ) is relatively more flexible and twistable. In the case of a core wire 10cw extending through the proximal portion 10p , the portion of the core wire near the proximal end of the device 10 may have a much larger outer diameter.

The core wire 10 cw alone is particularly flexible and particularly increases the ease of indentation and torque transfer of the torsional coil 10c . In combination with the core wire (10 cw ), the distal portion is much more effective at delivering indentation and torque applying forces without buckling or twisting. In addition, the core wire 10 cw can be plastically deformed or memorized in a bent shape, an example of which is shown in Fig. The bend 10b provides a steerability function to allow the operator to apply a torque to the device about the longitudinal axis of the device, as indicated by the arrows in Figure 5, to move the distal end of the device 10 in a different direction . In some embodiments, such bending can be performed by the operator during the procedure, which allows the observation through the scope to be made such that the guide wire 10 is inserted at an offset angle from where the straight direction along the longitudinal axis of the device will direct it, May be particularly useful in combination with scope 1008, since it may be clear to the operator what needs to be done. In some embodiments, the guide wire 10 does not have a core wire. In these embodiments, an outer jacket (e.g., coil, cable tube, laser-cut hypotube, braided polymer tube, etc.) provides support for torque, ease of indentation and tension. The advantage of not having a core wire is that the entire inner diameter of the guidewire is available to fill with the illuminating fibers.

The illuminating fibers can move freely in the radial direction within the device as described above. It is also not necessary to center the illumination fibers 10 i relative to the device 10 at the distal and proximal ends of the device. Figure 6 is a cross-sectional view of the distal end portion of the apparatus 10 showing the core wire (10 cw) fixed to the coil (10 c), wherein one trillion people fiber (10 i) is located adjacent to the core wire (10 cw) But is not fixed to the core wire 10cw or the coil 10c .

Plastic or glass lighting fiber (10 i) of the device shown in Figure 4 to typically a light source such as provided in the operating room for use by the endoscope, for example, transmission light from a xenon light source, a halogen light source, metal halide light source, etc. . Alternatively, the apparatus 10 may be configured to transmit light from another light source, such as a laser light source, wherein the laser fiber 10f replaces the illumination fiber described above, and as shown in the cross- Will extend through the device 10 in an optical fiber bundle. An optical fiber bundle to enhance the contribution applied to (bending and torque applying operation than in all), traceability, the steering torque and the other the stiffness of the device 10. Similarly, an illumination fiber (10 i).

Fig. 8 shows another embodiment of the illumination guide wire 10. Fig. In this example, the proximal end portion of the device 10 is formed externally by a coil laminated on top of the polymer layer, but any other arrangement described above can be substituted. In this example, the illumination is provided by a high brightness light emitting diode (LED) 10 id installed at the distal end of the device 10. The proximal end of the device 10 may be attached to the device 10 in order to prevent pulling the wire 10w at the connection with the LED 10 id and also to seal the proximal end of the device, May be sealed with any other alternative means described above with respect to the proximal end of the body 10. Since the proximal end of the device 10 of Fig. 8 does not transmit light, grinding and polishing are not required.

The apparatus 10 of Fig. 8 performs substantially similar to apparatus 10 of Fig. 4 with respect to ease of indentation, torque transfer properties and tensile properties. However, the apparatus 10 of Fig. 8 does not require illumination fibers or laser fibers. Instead, a pair of insulated lead wires are electrically connected to the terminals (not shown) of the LED 10 id and then electrically connected to the length of the device 10 to extend in the proximal direction from the proximal end of the device 10 In the device 10. The free end of the wire 10w is configured to be connected to a power source, which acts as a power source, to deliver electrical energy thereto to illuminate the LED 10 Id . Figure 9 shows a cross-sectional view of the distal end portion of the device 10 of Figure 8. In this example, the core wire 10 cw is in the form of a flat distal end core wire or shaped ribbon, as known in the art, extending between the two wires 10 w . Fig. 9 also shows the insulating layer 10 iw on each wire.

Any of the devices 10 described herein may optionally be provided on and / or along the tip of the device 10 to enhance visibility by the fluoroscopy system, the IGS system or other visualization system. And may include one or more radiopaque markers and / or electromagnetic coils at some other location.

Figure 10 shows an alternative design of the device 10 in which light is emitted in a proximal direction from the distal end of the device. This configuration can employ any of the various optical transmission means described above (e.g., illumination fiber, laser fiber, LED). The proximal portion 10p may be configured in any of the ways described above with respect to other embodiments of the apparatus 10. [ The distal portion (10 d) includes a transparent portion of the proximal end (dp 10) which is mounted on the distal end of the proximal end portion (10 p) of the device 10. The transparent portion 10 dp allows the light emitted from the illumination member 10 i or 10 id to pass out of the device 10 at the position of the transparent portion 10 dp . Thus, the illumination member (s) 10i or 10 id are terminated at the proximal end portion 10 dp of the distal end portion of the device 10. Distally from the transparent portion (10 dp), a distal portion (10 dd) of the distal end portion (10 d) of the device 10 extend a flexible guide wire distal end portion or tip. This flexible guidewire tip or tip 10dd may include a coiled section 10c and may optionally include a core wire 10cw in the manner described above with respect to Fig. The light emitted from the illuminating fiber will naturally disperse through the transparent portion (10 dp ). Alternatively, a deflector 11, such as a convex mirror (e.g., parabolic or other convex) shape or other reflective surface, may be used to deflect the light / light emitting portions 10i , 10 id ). &Lt; / RTI &gt; Additionally, or also as an alternative, the illumination fiber (10 i) may be bent at its distal end portion for directing the light emitted out through the transparent portion.

This configuration may be beneficial to further protect against injury from a foreign object in the body inside the light emitter (s) (10 i, 10 id) , and lights can be caused by the emitter structure and buditchim in the body. In addition, the flexible guide wire distal end portion (10 dd) of this type can provide greater flexibility and operability than the apparatus the illumination light emitter located on the distal tip of the device.

The transparent portion 10 dp may be provided as a transparent plastic or glass integral tube, or it may have an opening or window 10 t provided therein (see also Fig. 10). Further alternatively, the transparent portion is a plurality of struts disposed in a circumferential direction to the connecting distal, flexible tip (10 dd) a proximal end portion (10 p) and the cross of the device 10 as shown in Fig portion of Figure 12 (10 &lt; st &gt;). Alternatively, the member (10 st) can be crossed with another configuration or cage structure that is similar to the cross-shaped cage. In any of these alternative arrangements , member 10st may be transparent, but need not be, and may be formed of a non-transparent material, such as, for example, metal or opaque plastic.

The device 10 may include an attachment for providing illumination to position the guide wire 10 and / or other device during the procedure, a removable device for allowing the other device to slide onto the guide wire 10 from its free proximal end , And be easily detachable from and connected to a power source, for example, to enable reattachment to provide illumination again to assist in guiding / visualizing the device being passed over the guide wire 10.

Figure 13a and 13b shows an example of a coupler 20 that is configured for quick connect and disconnect of a light guide wire 10 employing the illumination fiber (10-i) or a laser fiber (10 f). Coupler 20 is coupled to a light source 1030, such as, for example, a conventional endoscopic light source, or other light source, preferably capable of delivering at least 10,000 lux through coupler 20. An optical cable 1032 optically connects the connector 20 with the light source 1030 to transmit light from the light source 1030 to the connector 20. The optical cable 1032 can optionally be a fluid-filled optical cable, such as a type provided, for example, with a DYMAX BlueWave ™ 200 and an ADAC Systems Cure Spot ™ optical cable. The liquid filled optical cable includes a photoconductive liquid core within the plastic tubing. The liquid is non-toxic, non-flammable and transparent at 270 to 720 nm. The ends of the liquid filled optical cable can be sealed with metal spiral tubing and high quality quartz glass enclosed by plastic sleeves for external protection.

The connector 20 includes a proximal channel, slot or bore 22 having an inside dimension or circumference slightly larger than the outside diameter or circumference of the device 10 at the proximal end portion 10p . A quick release locking mechanism 24 is provided for locking and unlocking the device 10 within the connector 20. Quick-release locking mechanism 24 has a locking portion (24 a), the channel, slot or bore 22 even channels, slots or bores (22) when press-fitted into and that is not inserted into the guidewire 10 of the mechanism 24 To a locking position shown in FIG. The locking mechanism 24 may be spring-biased, for example, toward the locked position. The locking mechanism 24 may also include ball and detent devices or other temporary locking means to maintain the mechanism 24 in a locked configuration. A further similar mechanism may be provided for temporarily locking the locking mechanism 24 in the non-locked configuration shown in FIG. 13A. It will be apparent to those skilled in the art of mechanics, such as alternative locking means, such as, for example, pivoting locking arms, that can be manually pivoted between a locked orientation and a non-locking orientation, or a foldable silicone valve, Other mechanisms may be employed.

Optical cable 1032 generally has a much larger inner diameter than the inner diameter of the inner diameter, or a combination of one trillion people fiber (10 i). The proximal end portion of the connector 20 is substantially equal to or slightly larger than the inner diameter or combined inner diameter of the illuminating fiber (s) and having a proximal inner diameter that is substantially equal to or greater than the inner diameter of the cable 1032, or Shaped passageway 26 that is tapered to a distal inner diameter that is approximately the same as or slightly greater than the outer diameter of the proximal end of the device 10. The tapered or funnel- The optical cable 1032 typically has a bundle of illuminated fibers of a larger diameter than those accommodated in the illumination guide wire 10. [ Thus, the taper 26 is used for transferring between a larger bundle within the optical cable 1032 and a smaller bundle within the guide wire 10. [ With this arrangement, light transmitted through the optical cable 1032 can be focused or focused along the path, so that much of the light can be transmitted through the illumination fiber.

To insert the device 10 into the connector 20, the operator retracts the quick-connect locking mechanism 24 to the open position shown in FIG. 13A. When the quick-connect mechanism 24 is provided with a temporary fixture as described above, the quick-connect locking mechanism 24 can be temporarily fixed in the orientation shown in FIG. 13A without the operator having to keep it open . Otherwise, the operator will keep the connector 20 open to the position shown in FIG. 13A. The proximal end of the device 10 is then inserted into an open channel, slot or bore 22 and the connector 20 is inserted until the proximal end of the device 10 is adjacent the proximal end of the channel, As shown in FIG. Then quickly the releasing mechanism is released by the operator, or if it is released from the open configuration the locking (prepared in the example of when the temporary locking mechanism for holding the quick-release to the open configuration do not) temporarily, the locking arm (24 a) above Is advanced toward the proximal end portion 10p of the device 10 by the convenience of the quick-connect locking mechanism 24. [ Locking arm (24 a) is with sufficient force to prevent them from that in the device (10) which is directed down and straight distal tip of the device 10 in the vertical direction not slide out of the connector 20, the locking arms (24 a ) And the device 10 under compression between the channel, slot, or opposite inner wall of the bore 22 to maintain the device 10. Alternatively, the locking arm (24 a) can also be a ball and detent mechanism, or other temporary locking mechanism as described above, it is locked temporarily in place. To remove the device 10 from the connector 20, the quick-connect locking mechanism 24 is repositioned in the open or non-locking orientation shown in Figure 13a, and when the device is released from the connector 20 Lt; / RTI &gt; to the connector.

14A and 14B show an alternative connector 20 that includes a quick release locking mechanism 24. In this example, at least two locking arms (24 a) is provided circumferentially around the distal end of the connector 20. The arm (24 a) is biased with a closed or locked configuration as shown in Figure 14a. For example, the arm 24a may be made of a resilient spring steel, a nickel-titanium alloy or an elastic plastic, and when mounted to the connector 20 and in a non-biased state, As shown in FIG. The installation of the device 10 into the connector 20 is simplified by the automatic gripping and temporary locking function provided by the quick release locking mechanism 24. [ The proximal end of the device 10 is simply inserted between the two or more arms (24 a). The arm (24 a) comprises a ramp type (ramped) or kaemhyeong (cammed) surface (24 b) for guiding the proximal end of the device 10 into the connector 20, the device 10 that these surfaces (24 b ), the arm (24 a) when turned naejil push the butt is convenience to the open, convenience the arrangement shown in Figure 14b. Convenience / of the arm (24 a), the elastic is by applying a compressive force to the shaft of the device 10 through the temporary locking surface (24 a), is maintained in a bar such as the position shown in Figure 14b, the device 10 is held. To remove the device 10, with sufficient force to overcome the compression force and the friction force imparted by the operator arm (24 a), while the connector 20 is kept relatively jamming, pull the device 10 You just have to. Then the elastic arm (24 a) the ratio shown in FIG. 14a - is returned to the comfort configuration. Alternatively, the arm (24 a) is or can be coated with a friction enhanced surfaces such as rubber or other elastomers may contain it, and / or, for example, crude by nulling (knurling) or other surface roughening techniques cotton .

In the example shown in Figs. 14A and 14B, the optical cable 1032 provided has an inner diameter substantially equal to the diameter of the proximal end of the device 10, and a tapered channel 26 is not required. However, in the case of a much larger arrangement of optical cables 1032, as in the case of using a conventional endoscopic light source 1030, the connector 20 is provided with the same method as described above with respect to the embodiment of Figures 13A and 13B A tapered optical channel 26 may be provided.

15 shows a longitudinal section view of a connector 20 connectable to and releasable from the guide wire device 10 and releasable therefrom and also typically connectable to and detachable from a standard light source cable found in the operating room. Thus, this connector 20 functions as both an adapter for connecting to a conventional endoscope light source channel or cable, and a quick release locking connector for connecting to and releasing from the proximal end portion of the guide wire 10.

The proximal end of the connector 20 is provided with a light post 28 configured to mate with a connector on the distal end of the optical cable extending from a conventional endoscope light source. For example, the light post 28 may be an ACM Lightpost (ACM Corporation) or other standard connector typically used to connect an endoscope to an operating room light source. Because the cable extending from the operating room light source generally has an inner diameter that is much larger than the inner diameter or combined inner diameter of the illumination fibers of the device 10 and greater than the diameter of the proximal end of the guide wire 10, The end portion includes a tapered or funnel-shaped light passage 26, similar to that described above with respect to FIG. 13A.

Quick-release locking mechanism 24 in this example includes a collet (collet) (24 c) configured to set a center of the proximal end of the device 10 with the distal end of the tapered passage (26). The cap in the direction for the screw thread is screwed on a mating thread (24 t) on the main assembly of the formed cap (24 d) a connector (20), the cap (24 d) with respect to the body of the connector 20 to move in the proximal direction eonhyeojyeo over (24 d) when the applied torque to the cap (24 d) type inside the lamp or kaemhyeong surface (24 e), the outer ramp-like or kaemhyeong surface (24 f) of the collet (24 c), the device 10 a is caused to function as a pin vise (pin vise) and a clamping collet (24 c) on the proximal end portion of the device 10 for clamping and holding the current position for the connector 20. In order to insert the device 10, the cap (24 d), the collet (24 c), the inner channel proximal end larger dimensions than the outer diameter of the (24 g), the device 10 from those described above in order to open parts of the distal opening of the to be rotated in the opposite direction, so that the proximal end of the device 10 can be easily slid over the collet (24 c), the channel (24 g), the device 10 until the adjacent or close to it on the proximal end portion of the . Then the cap (24 d) is rotated about the main body of the connector 20 for clamping in a suitable device 10, as described above position. Removal of device 10 can be performed by loosening the grip of the collet (24 c) of the device 10 is rotated in the opposite direction to the cap (24 d) to the connector body 20, and then the device ( 10 can easily slide away from the connection with the connector 20. The components of the connector 20 can be made of, for example, a metal such as stainless steel or other biocompatible metal, or a heat resistant thermosetting polymer.

The light post 28 is rotatable relative to the optical cable 1032 of the light source 1030 when the connector 20 is connected to the distal end connector of the optical cable 1032. This allows device 10 to be rotated during use without creating significant torsion or rotational resistance in optical cable 1032 when connected to connector 20 in this arrangement. For example, in the illustrated light post 28, and the female receptacle (receptacle) (not shown) of an optical cable 1032 is engaged in the light post 28 is coupled over a groove (28 g), then in the surrounding The female receptacle is rotatable relative to the light post 28. 16 is a longitudinal section of connector 20 similar to connector 20 described above with respect to FIG. One difference in the example of Fig. 16 is that tapered light guide 26 is provided in light post 28 as opposed to being provided in the proximal end portion of the body of connector 20 in Fig. However, in both cases, the functionality is the same.

Referring now to Figures 17A-17E, there is shown a view of a partial tubular cross-section through the human head, illustrating various steps of a method for treating the pores opening into the frontal sinus. The methods described herein and all other methods disclosed herein may also include cleaning or washing anatomical structures within the nose, sinus, nasopharynx, or adjacent structures, including, but not limited to, have. The step of cleaning the target anatomical structure may be performed before or after the diagnostic or therapeutic treatment procedure. The methods of the present invention may also be used to deliver vasoconstrictors (e.g., 0.025-0.5% phenylephrine or oxymetazoline hydrochloride (NEO-SYNEPHRINE or AFRIN) Nasal cavity, nasopharynx or nearby structures for the treatment, such as spraying or washing with an anti-bacterial agent (eg, povidone iodine (BETADINE)) for washing tissue, etc. &Lt; / RTI &gt;

17A, a first introducer in the form of a sinus guide 1002 is introduced through a nostril and through the nasal cavity 1012 to a position adjacent to the pores 1034 of the frontal pedal 1036. [ The sinus guide 1002 may be as previously described herein, or may be as described in the application incorporated herein by reference. The advancement of the sinus guide 1002 can be visualized with the scope advanced as close as possible to the pores 1034 without causing significant trauma to the tissue inserted therein and into the nasal cavity 1012. [

Once the surgeon is sure that the distal end of the sinus guide 1002 is positioned sufficiently close to the appropriate pore 1034, the light guide wire 10 connected to the light source as described above by any of the above-mentioned techniques Is inserted through the sinus guide 1002 and advanced therethrough, see FIG. 17B. There may be some transmissive illumination from the light emitted from the scope that can be used to confirm that the sinus guide 1002 is located in the correct general area and this confirmation is made by the distal tip of the guidewire 10, May also be done before exiting the distal end. However, when the tip of the guide wire 10 exits the distal end of the guide 1002, and in particular when the light-emitting portion of the guide wire 10 contacts or is intended to approach an intended target surface, such as the inner wall of a sinus, A much larger specific transmission light effect is produced. When the guidewire 10 is advanced, the transmission illumination on the patient's face can be observed as a shining point moving as the distal end portion of the device 10 moves, so that the radiation transmitted, for example, by fluoroscopy Allowing the location of the light emitting portion of the device 10 to be tracked visually without the need for imaging.

As shown in Figure 17C, the photoactive drug 1037 may be injected into the body of the patient. Drug 1037 may be injected into any available space within the patient to facilitate transmission illumination. In one approach, the drug is injected into the sinus for this purpose. Illuminating the light source into the medication improves the effectiveness of the lighting device.

Although forehead light 1036 may have some diffuse transmission illumination on the forehead 1036 of the patient as the light emitting portion of device 10 approaches the pore 1034, (More concentrated) as it passes through the frontal furrow 1036 and becomes brighter and smaller in size (see FIG. 17D). When the device 10 is further advanced, the shining point becomes the most clear and brightest as the light-emitting portion approaches and contacts the wall of the frontal 1036. Also, as noted, the movement of the transmission-illuminated point may cause the guide wire 10 to move within the position of the sinus, as can be ascertained by the surgeon's knowledge of the particular anatomical structure of the patient being treated And can be traced visibly to confirm that In this regard, in order to inform the surgeon of any specific or unusual pattern within the sinus anatomy of the individual patient that may be useful for tracking and identifying where the guide wire is located, as indicated by transmission illumination, A CAT scan or other image of the anatomical structure may be performed prior to such procedure and reviewed by a surgeon.

Once correctly positioned, the proximal end of the device 10 is disconnected from the connector 20, leaving the guide wire 10 in its present position. An actuating device 1006, for example a balloon catheter, is introduced over the guide wire 10 and the proximal end of the device 10 is advanced over it so as to extend in the proximal direction beyond the proximal end of the device 1006. The device 10 is then reconnected to the connector 20 such that light is again emitted from the light emitting portion of the distal end portion of the device 10. Thus, when the actuation device 1006 is advanced towards the pore 1034, the distal end portion of the guide wire 10 is accurately held within the frontal pawl 1036 and the balloon of the actuation device 1006 extends across the pore Can be visually confirmed without radiographic inspection, see Figure 17d. Accurate positioning of the operative end (distal end portion) of the actuating device 1006 can be visualized by scope and / or fluoroscopy.

Once the correct placement of the actuation device 1006 is confirmed, the actuation device 1006 is used to perform the diagnostic or therapeutic procedure. In this particular example, the procedure is an extension of the frontal fossa 1034 by expansion of the balloon to expand the opening of the fistula 1034. However, it will be appreciated that the present invention may also be used to expand or modify any sinus pores or nose, sinus, nasopharynx or other artificial or naturally occurring anatomical openings or passageways in adjacent areas. Other operating tools may also be inserted and used in accordance with these same techniques. After completion of the procedure, the sinus guide 1002, the guide wire 10, and the operating device 1006 are withdrawn and removed to complete the procedure, see Fig. 17E.

The illumination guidewire device 10 also facilitates visualization and placement of the sinus guide 1002 in the procedures described with respect to Figs. 17A-17E, or in other procedures where a sinus guide, guide catheter or guide tube is placed in the sinus path . &Lt; / RTI &gt; Figure 18 illustrates a situation similar to that described above with respect to Figure 3, with the scope 1008 inserted as far as possible without causing significant trauma to the patient. In this case, the range of the clock extends in the distal direction from the scope 1008 and does not extend all the way to the pores 1034, as schematically indicated by the ray 1009 shown. In this case, proper visualization of the sinus guide 1002 by the scope 1008 is possible only to the extent of the ray 1009 shown. Thus, if the sinus guide 1002 is sufficiently flexible to be advanced closer to the pores 1034, proper visualization of such movement will not be possible via the scope 1008. [ That is, if the sinus guide 1002 could physically extend further distally to place its distal end at the entrance of the pore 1034, the scope 1008 would not be able to properly visualize it. However, by inserting the illumination guide wire through the sinus guide 1002 as shown in FIG. 18, additional illumination can be provided on the circle of the illumination range of the scope 1008. This additional illumination can be accommodated by the scope 1008 to allow visualization of the illumination portion of the device 10 and potentially even extension of the illumination range of the device 10 as long as there is a straight view path. have. Thus, the advancement of the sinus guide 1002 can be visualized all the way farther and potentially in the distal direction by the scope 1008 using this technique.

This technique may also be used to visualize the placement of the guide wire 10 into and through the desired pores 1034. [ Alternatively, it may be performed without the sinus guide 1002 where the guidewire 10 is inserted and the scope 1008 is exposed by the scope 1008 in addition to the light emitted by the guidewire 10, Can be used to visualize the placement of the guide wire 10 into the target pore with the help of the light that is emitted.

In any of these procedures where the scope 1008 is used for visualization and the illumination guide wire is inserted, only some transmission illumination of the target sinus can be generated from the light emitted by the scope 1008. However, this transmissive illumination will be diffuse and will exhibit a large area of transmission light that is slightly hazy on the skin of the patient. When the illumination guide wire is inserted and advanced, a brighter transmission illumination point will be seen, as previously mentioned, which is smaller than when the illumination portion of the guide wire enters the sinus. In addition, even before entering the sinus, the light emitted from the guide wire will create a moving transmissive illumination point at which the guide wire 10 advances, which, in addition, for any diffuse transmission illumination produced by the scope light, To help distinguish the location of the distal portion of the heart.

When the guide wire 10 is advanced into a pore other than the target pore (e.g., the pore 1035 shown in Fig. 18), this can be observed by the scope 1008 according to the line of sight. However, if not, the transmission illumination due to entry into the sinus different from the target sinus will be evident by the different locations on the patient &apos; s face. Also, in the illustrated example, the guide wire 10 will not be able to be advanced farther through the pores 1035 before it is redirected and dried by a relatively small sinusoidal space where the pores 1035 are followed. Thus, by tracking the movement of the illumination point created by the guide wire 10, the surgeon tries to change the direction of the guide wire 10 because the guide wire tends to be redirected by a much smaller space than is characterized by the target frontal surface 1036, It can be confirmed that the mobile phone 10 is misplaced.

Thus, by using the illumination guide wire device 10 in the manner as described above, the use of fluoroscopy or other X-ray visualization can be reduced and is not required in some cases to confirm the correct placement of the guide wire.

Similar procedures can be performed within other sinuses. For example, a procedure similar to that described above with reference to Figs. 17A-17E can be performed to open or expand the opening of the pore leading to the maxillary sinus. In this case, when the light guide wire device 10 passes through the pores opening into the target maxillary sinus and into the maxillary sinus, a relatively bright, relatively small, clear transmission illumination point can be observed to move across the patient's ball area . When the guide wire 10 is advanced farther in the distal direction along the maxillary sinus, the maxillary sinus typically tends to move downward relative to the skull, and the base wall of the maxillary sinus is very close to the patient &apos; s palate. Thus, when the illuminated portion of the guidewire approaches / approaches or contacts the basal wall of the maxillary sinus, the transmissive illumination point can be observed on the patient &apos; s ceiling by looking into the patient &apos; s mouth. At the same time, the transmitted illumination spot on the ball induced by the guide wire will weaken at this time or not at all. This visibility on the mouth ceiling is an additional confirmation that the guide wire has entered the maxillary sinus. The movement of the transmission illumination point on the entrance ceiling can also be observed when the guide wire 10 is advanced and / or retracted.

It is further noted that some wavelengths of light may be more effective in generating the transmitted illumination effect described herein for the purpose of positioning the guide wire. In this regard, a particular wavelength of visible light may be selected for this purpose. Alternatively, or additionally, infrared wavelengths may be particularly effective. In this regard, the guide wire employing the illumination fibers may be provided with a filter 12 to limit the color / wavelength of the light emitted by the device 10. [ 19, the filter 12 may be positioned on a circle of illuminating fibers, such as the distal tip of the device 10, proximal to the illuminating fiber, such as the proximal end of the device 10, May be provided in a light path at a location within the light path (20). Multiple filters may be placed in one or more of these locations. In the case of an apparatus 10 employing LED light emitting components, LEDs of different colors may be employed to emit different wavelengths of light. In the case of an apparatus 10 employing laser fibers, different types of lasers emitting different wavelengths of light may be used.

Another optional feature that may be provided to guide wire 10 is the ability to emit flash, flashing or flashing light. The transmission illumination produced by the flashing light can be further distinguished from the diffusion transmission illumination produced by another light source, for example an endoscope, because the transmission illumination produced by the guide wire 10 in this case Because it will flash or change in intensity brightly and blurred. To produce this type of light, a light source with flash capability may be coupled to the device 10, or such capability may be provided to the connector 20. [ When using a laser light source or LED as a light emitter, as in the above embodiment, flashing and flashing effects can be generated electronically in accordance with techniques known in the electronics and lighting arts. 20A is a schematic view of a portion of the vane 27 v and the vanes 27 v for alternating the emission and blocking of light transmission through the device 10 out of the connector 20 and ultimately when the device 10 is connected thereto. a gap (27 g) and (FIG plan view of 20b) is so aligned in a row with the light path through the connector 20 rotates the shutter 27 is schematic illustration of the connector 20 that is possibly mounted rotating inside . The shutter 27 may be powered by a motor 29, which may be battery-powered or connectable to an operating room power source, and the motor 29 may be configured to operate and stop the motor, Can be actuated by the user through the actuator 31 which can be configured.

Alternatively, extends through a slot in the shutter 27 has vanes (27, v) the connector 20, the user is configuring the shutter in order to blink the light emitted from the device 10 to be able to manually rotate the .

Other features designed to be inserted into the sinus, or at least to be located in the pores of the sinus, may also be provided with illumination capability according to any or all of the features described above with respect to the illumination guide wire. FIG. 21 shows a frontal opening extractor 100 mechanism that can be used to access the sinusoidal pores. For example, the searcher 100 may be provided with a ball tip at one end or both ends of a length and a length of from about 175 mm to about 250 mm (about 208 mm in the example shown). In Fig. 21, the searcher 100 is also provided with a light emitter 104, which can be used to locate the end of the device 100 by the transmission illumination effect discussed above when it is being advanced to search for pores, (100). The light emitters 104 may be provided by, for example, LEDs, light illuminating fibers or laser illuminating fibers. One or both end portions of the device may comprise an optical fiber bundle or wire for connecting to a light source or a power source in the manner described above.

22 illustrates a suction sinusoidal device 110 configured to drain blood and / or other fluid from a target surgical site, such as the frontal sinus, sphenoid sinus, or other sinuses, to improve the visibility of the surgical procedure. The instrument 110 includes an elongate shaft 116 having a distal end that is open to deliver a suction force through the suction lumen end 112. Also provided at the distal end of the shaft 116 is a light emitter 114, which may be an LED or more than one illuminated fiber configured to transmit light in the manner described above. Shaft 116 is configured and dimensioned to be inserted into the sinus passages and sinuses. The proximal end portion of the instrument 110 may include an optical fiber bundle 118 or wire for connecting to a light source or a power source in the manner described above.

23 shows an integral wire expanding catheter 120 that includes an elongate flexible catheter shaft 126 with a balloon 128 mounted thereon. A proximal Luer hub 122 is attached to the proximal end of the catheter shaft 126. An inflation device (not shown) may be attached to the luer hub 122 and used to inflate and deflate the balloon 128. A non-removable integral guide member 124 extends beyond and beyond the distal end of the catheter shaft 126. The guide member 124 may extend through and extend in the proximal direction of the length of the catheter shaft 126, as shown in FIG. The proximal end portion may be comprised of a polished proximal end comprising the illuminating fibers as described above or may have one or more wires extending in the proximal direction for connection to a power source for delivering power to the LED, . A light emitter 125 may be provided in the distal tip of the integral guide member 124 as shown in FIG. 23 and may be one or more LEDs or one or more illuminating fibers, depending upon any of the various embodiments described above. have. Alternatively, the light emitter 125 may be provided at the proximal end of the distal tip of the guide member 124, for example, in the manner described above with respect to FIG. Alternatively, the guide member may not extend through the entire length of the catheter 126, or may not extend at all from the balloon member 128 in the proximal direction. In these examples, the light emitter may be an LED, wherein the wire may extend through the catheter 126 or in conjunction therewith and into the guide member 124 for connection with the LED. Alternatively, if the light emitters 125 comprise more than one illuminating fiber, the illuminating fibers may extend from the proximal end of the guide member 124 in a proximal direction, and in a guide wire configuration, Lt; RTI ID = 0.0 &gt; 126 &lt; / RTI &gt;

In one preferred embodiment for adult applications, the balloon catheter 120 has an overall length of approximately 43.5 cm, and the shaft 126 has an outer diameter of approximately 1.473 mm (0.058 inch). Additional details regarding an integral wire expanding catheter in which a light emitter can be constructed in the manner described herein may be found in U.S. Patent Application Serial No. 60 / &Quot; Catheters with Non-Removable Guide Members for Use in Treatment of Sinusitis ", filed 11 / 438,090. Application Serial No. 11 / 438,090 is hereby incorporated herein by reference in its entirety.

Referring now to FIGS. 24-31, there is shown an illumination guide wire 210 according to another embodiment of the present invention. Light guide wire 210 may include a long flexible housing including a distal end portion (210 d) and the proximal end section (210 p) (or "main body"). Guide housing (210 d, 210 p) of the wire 210 may be coupled by the connector 20 and the proximal is more fully below.

In general, the distal end portion (210 d) may be more flexible than the proximal end section (210 p) in order to provide a desired degree of flexibility for guiding the device to another location in the body portion or in the sinus. Distal end portion (210 d) may comprise a coil (210 c) as its outer portion to aid in providing the desired flexibility property to this part. The proximal end portion of the light guide wire (210) (210 p) when the device is inserted through another device, such as always patient proximally out (and sinus guide, including the deepest expected position the distal end of the device is disposed, (In the proximal direction outside the device into which the illumination guide wire 210 is inserted). As before, the proximal end section (210 p) is to have a visible marking to be spaced at equal intervals and preferably that can be observed by the user to ensure that the placement in the patient to where the light guide wire 210, have. Ability to the proximal end portion (210 p) is typically achieved before torque, that is, applying a torque to the proximal end section (210 p) from a location outside of the patient, and delivering the torque to the distal end section (210 p); Press-ease, i.e., move the operator to the proximal end section (210 p) a When sliding, pressing force is transmitted to the distal portion (210 d) distal without buckling the device 210 portion (210 p) from a location outside of the patient Stiffness sufficient to allow; And a tensile strength that allows the operator to pull the proximal end portion 210 p out of the patient's location and withdraw the device from the patient without significant plastic deformation or any degradation of the device.

A coil formed in the distal end portion (210 d) of the illumination device (210) (210 c) may be formed of stainless steel wire. The diameter of the coil wire may be about 0.102 to about 0.203 mm (about 0.004 to about 0.008 inch), typically about 0.152 mm (0.006 inch). Coil (210 c), an alternative material which can be formed from which the El jilroyi (R), Connie chromium (R) or other biocompatible cobalt-chromium-nickel alloy; Nickel-titanium alloy; Or other known biocompatible metal alloys having similar properties. In one approach, the coil is formed of 0.162 mm (0.006 inch) stainless steel wire defining an outer diameter of 0.064 inches (0.038 inches maximum) and an inner diameter of 0.033 inches (0.533 millimeters).

In one embodiment, the proximal portion 210 p may be fabricated from a cable tube 211 (see also Fig. 26). As used herein, the "cable tube" refers to any structure other than the tubular pipe made of a single coil (e.g., coil (210 c)). Cable tube 211 may be limited to a constant internal diameter of approximately 0.533 ㎜ (0.021 inches) to match the inner diameter of coil (210 c). Also, the cable conduit 211 may be formed of 12 to 13 filar of steel wire wound to achieve maximum stiffness. Distal part of the cable tube 211 may be formed tapered to provide a smooth connection to the coil (210 c). This tapered profile can be formed by grinding the outer surface of the cable pipe 211. In one embodiment, the proximal portion 210 p made of the cable tube 211 can provide significantly greater torque transfer and indentation than the distal end portion 210 d made of the coil 210 c . Conversely, the distal end portion (210 d) may be holy more flexible than the proximal portion (210 p). As shown in Figure 25, the coil (210 c) is bonded to the proximal portion (210 p) by solder, epoxy or other adhesive or by mechanical joints. In one approach, the coil (210 c) has a length in the range of 5 to 8 ㎝, cable tubes (that is, the proximal portion (210 p)) is a length of 60 to 100 ㎝. One or more illumination channels for the illumination fibers 210 i are provided in the guide wire 210 and extend along its length. The illumination channel is configured to transport light from the proximal end of the illumination guidewire 210 to the distal end of the device and out therefrom. One or more illumination channels may each be provided that includes plastic illuminated fibers. As previously described, the plastics used to make the illuminating fibers are blended for light transfer properties in accordance with techniques known in the art and available in the art. Therefore, Eska (Mitsubishi Rayon) high performance plastic optical fiber having a concentric two-layer structure with a high purity polymethyl methacrylate (PMMA) core and a thin layer of specially selected transparent fluoropolymer cladding can be used. In a preferred approach, the assemblies include two illuminating fibers each having an outer diameter of about 0.254 mm (0.010 &quot;). However, the illuminating fibers may have an outer diameter in the range of about 0.127 mm (0.005 inch) to about 0.254 mm Alternatively, a single plastic illuminating fiber having an outer diameter of about 0.508 mm (0.020 &quot;) may be used. Also, glass illumination fibers with much smaller outer diameter, e.g., about 0.051 mm (0.002 &quot;), can be substituted. In this case, more of the illuminating fibers can be provided in bundles, for example about 6 to 50 glass fibers can be provided.

The distal end of the light guide wire 210 is sealed by a (one or semi-transparent) which may be in the form of a transparent epoxy or another transparent or translucent adhesive or sealing material seal (210 s). The seal (210 s) and will maintain the distal end of the illumination fiber (210 i) that match the distal end of the device, provides a lens 213 to provide a non-traumatic tip. In one approach, UV adhesive is employed to bond a core wire and an illumination fiber (210 i) to the coiled wire (210 c). In addition, the seal (210 s) will prevent the introduction of foreign matter into the apparatus. The lens 213 formed at the distal end may be designed to focus or distribute light when light is emitted therefrom in order to achieve a maximum transmitted illumination effect. The distal end may also include a prism or diffractive element.

Still referring to Fig. 25, in some embodiments, the guide wire 210 may also include an inner core wire 210cw (or " core wire &quot;). In one embodiment, as shown in Figure 25, the core wire (210 cw) can be extended to the proximal end of the proximal section (210 p) from the distal end of the distal portion (210 d) of the guide wire 210 and , may be attached to the distal end, a coil (210 c) and a cable tube 211 at the junction between the coil and the proximal end portion (210 c) and a cable tube (211). In various embodiments, the core wire 210 cw may be attached by any suitable means, such as laser welding, epoxy or other adhesive or mechanical fastener. In one embodiment, the core wire 210 cw may be formed of a Nitinol (nickel-titanium alloy) metal alloy that is biocompatible and provides the required stiffness and torque transfer.

Core wire (210 cw) is alone considerably increases the flexibility and ease of the press-torsion torque around the achievement of possible coil (210 c) in particular. In combination with the core wire 210 cw , the distal portion 210 d is much more effective at delivering indentation and torque applying forces without buckling or twisting. Also, the core wire 210 cw can be plastically deformed or memorized in a bent shape, an example of which is shown in Fig. The bend 10b provides a steerability function to allow the operator to apply a torque to the device about the longitudinal axis of the device, as indicated by the arrows in Figure 5, to move the distal end of the device 10 in a different direction .

27 and 28, the core wire 210 cw may be formed as a long member. When so formed, the core wire 210 cw may be ground to different diameters to provide varying amounts of rigidity and torque transfer along the illumination guide wire 210. As part of the light guide wire (210) assembly, the core wire (210 cw) it is configured to provide space for an optical fiber (210 i). Accordingly, the major dimension of the core wire (210 cw) must be less than the inner diameter of the proximal portion (210 p).

27, in one embodiment, the core wire 210 cw may include a distal end portion 219 having a nominal diameter of 0.076 mm (0.003 inch) and a length of approximately 1.0 centimeter. The proximal adjacent section 221 may have a diameter of about 0.152 mm (0.006 inches) and a length that extends about 4.0 centimeters from the end of the member. A tapered region 223 is configured in the proximal of this structure, increasing in size from a terminus to a nominal diameter of about 0.203 mm (0.008 inch). The remaining proximal orientation section 225 of the core wire 210 cw may implement a constant 0.203 mm (0.008 inch) diameter. In this manner, sections of various dimensions of the core wire 210cw can provide desirable flexibility.

In an alternative embodiment, Reference is now made to Figure 28, the core wire (210 cw) may include a structure for receiving part of the transition to the proximal portion (210 p) from the coil (210 c). The short termination portion 231 (approximately 0.2 cm in length) of this embodiment is flattened for attachment (e.g., soldering) purposes. A support (210 cw) is then to form a 0.127 ㎜ (0.005 inch) diameter 233 over the approximately 1.3 ㎝, from about 1.5 ㎝ to 5.0 ㎝ from the terminal end, the support (210 cw) from about 0.203 ㎜ (0.008 in.) Lt; RTI ID = 0.0 &gt; 235 &lt; / RTI &gt; At approximately 5.0 cm to 8.0 cm from the terminus, the core wire 210 cw has a proximal orientation tapered to approximately 0.152 mm (0.006 inch) in the proximal alignment section 239 after taking a diameter of approximately 0.203 mm (0.008 inch) And a distal enlarged section having a tapered section 237. This section 239 then increases to a maximum value of about 0.203 mm (0.008 inch) at a diameter of about 12.0 centimeters with respect to the terminus. And the proximal section 241 thereof maintains a diameter of about 0.203 mm (0.008 inch).

Referring now to FIG. 29, a core wire 210 cw may be secured within the illumination guide wire 210 by attaching a terminus 251 of the support 210 cw to the coil 210 c . At the junction 253 between the proximal and the coil (210 c) of the proximal portion (210 p) of the device 210, the proximal taper of the core wire (210 cw) distal of the enlarged section 238 can be constructed. These juxtaposed relationship of the core wire (210 cw) and a coil (210 c) and a proximal portion (210 p) facilitates relaxation of the rigidity in the region of the joint (253).

In an alternate embodiment, a 0.152 mm (0.006 inch) section 239 of core wire 210 cw is configured and a junction (not shown) between proximal portion 210 p and coil 210 c , 253 and at the terminating end 251. It should be appreciated that welding at the abutment 253 may require additional material (i.e., a steel ring) to complete the engagement between the parts. When a soldering approach is used, the inner diameter of the coil can be kept open by inserting a Teflon coated mandrel to fill the inner diameter. In this way, since there is a relatively shorter length of the core wire 210 cw to transmit the rotational force, the torque between the distal end and the proximal portion 210 p of the illumination guide wire 210 is significantly Can be increased. This approach may also include the removal of the connection between the proximal portion (210 p) and the core wire (210 cw) at the proximal end of the core wire (210 cw).

Referring to FIG. 31, another embodiment of the illumination guide wire 210 is shown. Herein, the core wire 210 cw is attached to the coil 210 c at its distal end 251 and is also between the proximal portion 210 p of the illumination guide wire 210 and the coil 210 c along the middle section As shown in FIG. The core wire 210 cw may also have a length considerably less than the length of the lighting device 210. The core wire 210 cw thus configured may have an end point 261 that terminates along an intermediate section of the illumination guide wire 210. The space occupied by the core wire 210 cw provides a region through which the optical fiber 210 i moves. In one embodiment, a 40 to 60 cm section may be provided for winding the fibers 210 i on the circle of the connector assembly 20. This can help prevent damage to the fibers 210 i during rotation of the illumination guide wire 210.

This has been observed that the thermal cycles can be applied to the illumination fiber (210 i). This is due to sterilization, aging, transport, fiber illumination and other factors. Such thermal cycling can lead to longitudinal shrinkage of the illumination fiber (210 i). In fact, 0.5 to 1% shrinkage can occur when the illuminating fiber is heated to 40 DEG C or higher. In conventional approaches, illumination fiber shrinkage can cause damage if the fiber is secured in a manner that does not compensate for shrinkage. The ends of the fibers may be torn or worn, thereby adversely affecting the function of the fibers. Various approaches are considered to deal with the contraction of the illuminating fiber. In one approach, the fibers can be pre-heat treated at about 70 캜 for 48 hours. By doing so, the fibers can be pre-contracted. This may minimize or eliminate further shrinkage at lower temperatures.

In another approach, referring now to Figures 31 and 32, a structure may be incorporated into the light guide wire assembly 210 to accommodate variations in length. As previously mentioned, the connector 20 is attached to the proximal end of the illumination guide wire 210. The connector 20 may be operably coupled to a power source or other light activation system. 32 and a cable tube 226 in the proximal end section (210 p) of the first embodiment of light guide wire 210 of the connector 220 that incorporates the structure for accommodating the optical fiber length variation, as shown in FIG. 33 And a luer connector 224 for receiving the luer connector 224.

The connector 220 also includes an internal bore 227 having a first section 229, a second section 232 and a third section 234 wherein the first section 229 and the third section 234 The second section 232 has a smaller diameter than the first section 229 and the third section 234. The second section 232 has a smaller diameter than the first section 229 and the third section 234. [ A first bore section 229 is formed in the proximal end of the connector 220 and sized radially to accommodate the centering sleeve 236. Sleeve 236 includes a bore sized to receive cable tube 226 and functions to center cable tube 236 within first section 229.

The third bore section 234 of the connector 220 extends in a distal direction from the proximal end of the connector 220. A centering grommet 240, which is in appositional engagement with the illumination fibers 210 i , is received in the rear end of the third bore section 229. The grommet 240 centers the optical fiber 210 i through the connection point 242.

A collet 244 is also attached to the proximal portion of the cable conduit 226. The collet 244 is sized and shaped to slide within the third bore section 234 having a length significantly greater than the length of the collet. Through its smaller diameter as compared to the first and third bore sections 229 and 234 disposed adjacent to each other, the second bore section 232 includes a centrally located centering sleeve 236 and a proximal position Lt; / RTI &gt; serves as a stop for both collets 244 that have been removed.

As mentioned, the proximal end of the illumination fiber (210 i) is attached to the centering grommet. And its distal end is joined to the distal end of the guide wire 210. However, the cable conduit 226 has a floating proximal end by its connection to the slidable collet 244. The collet 241 to move when the length of the illumination fiber (210 i) shrinkage, and such length shrinkage within the third bore section 234 of the connector 220 in the proximal direction (and the cable connected to the collet 244 (Tube 226). In this way, structural damage is avoided on the shorter length fibers one trillion people (210 i) of the.

34, in an alternative embodiment of the connector 220, the centering sleeve (236 in the embodiment of FIG. 33) may be omitted. 35 and 36, another alternative approach is shown. The proximal end of the illuminating fiber 210 i is attached to an optical fiber connector 243 configured within the proximal end of the inner bore 245 extending through the connector 220. In this embodiment, the inner bore includes a first section of larger diameter that is tapered to a smaller, constant diameter second bore section. The illumination fibers 210 i are received in a third bore section 243 having a smaller diameter than the first and second sections.

Also, a rigid grommet 247 comprising a first component of the rotation stop 249 is configured to be slidable within the first bore section. In addition, a second component of the rotation stop 252 formed therein is disposed within the first bore section. Thus, the grommet 247 is keyed with the connector 220 to control the degree to which the components can be rotated relative to one another. In one approach, rotation may be limited to 220 degrees or 150 degrees when two pivot stops 249, 252 are configured within the connector 220. [ The cap 253 holds the grommet 247 in the connector bore 245. In this configuration, the cap 253 prevents the grommet 247 from moving in response to the tension applied to the illumination guide wire 210. In addition, the bore 245 permits longitudinal translation of the cable tube attached to the grommet 247. In addition, transplantation of key, the connector 220, as discussed grommet relationship controls the allowable rotation of the cable tube 226, and thus the fiber (210 i) in accordance with. Therefore, the illumination fiber (210 i) are protected when this is the case, which tend to shrink and also a tensile force and the rotational force is applied to the device.

Referring now to Figures 37-38, an illumination guide wire 310 in accordance with another embodiment of the present invention is shown. Light guide wire 310 may include a long flexible housing including a distal end portion (310 d) and the proximal end section (310 p) (or "main body").

In general, the distal end portion (310 d) may be more flexible than the proximal end section (310 p) in order to provide a desired degree of flexibility for guiding the device to another location in the body portion or in the sinus. Distal end portion (310 d) may comprise a coil (310 c) as the outer portion to aid in providing the desired flexibility property to this part. The proximal end portion of the light guide wire (310) (310 p) when the device is inserted through another device, such as always patient proximally out (and sinus guide, including the deepest expected position the distal end of the device is disposed, (In the proximal direction outside the device in which the illumination guide wire 310 is inserted). As before, the proximal end portion 310 p may have a visible marking, preferably equidistantly spaced, that can be observed by the user to ascertain to what extent the illumination guide wire 310 has been placed in the patient have. The proximal end portion 310 p generally has the ability to achieve torque transfer, i.e., torque from a location outside the patient to the proximal end portion 310 p and transmit its torque to the distal end portion 310 d ; Press-in ease of use, i.e. when the make an operator to push the proximal end section (310 p) from a location outside of the patient, pressing force to advance the distal portion (310 d) is transmitted to without buckling the device 310, the distal portion (310 d) Sufficient stiffness to allow; And a tensile strength that allows the operator to pull the proximal end portion 310 p out of the patient's location and withdraw the device from the patient without significant plastic deformation or any degradation of the device.

Referring back to Figure 37, the coil (310 c) may be formed and a distal end portion (310 d) of the illumination unit 310, formed of stainless steel wire. The diameter of the coil wire may be about 0.102 to about 0.203 mm (about 0.004 to about 0.008 inch), typically about 0.152 mm (0.006 inch). Coil alternate materials capable of forming a (310 c) El jilroyi (R), Connie chromium (R) or other biocompatible cobalt-chromium-nickel alloy; Nickel-titanium alloy; Or other known biocompatible metal alloys having similar properties. In one approach, the coil is formed of 0.152 mm (0.006 inches) stainless steel wire defining an outer diameter of 0.064 inches (0.035 inches max) and an inner diameter of 0.033 inches (0.533 mm).

In one embodiment, the proximal portion 310 p may be fabricated with a cable tube 311. As used in this application, "cable tube" refers to any structure other than the tubular pipe made of a single coil (e.g., coil (310 c)). Cable tube 311 may be limited to a constant internal diameter of approximately 0.533 ㎜ (0.021 inches) to match the inner diameter of coil (310 c). In addition, the cable conduit 311 may be formed of five to twenty filers of steel wire wound with twelve to thirteen filers selected to achieve the desired stiffness. Distal part of the cable tube 311 may be formed tapered to provide a smooth connection to the coil (310 c). This tapered profile can be formed by grinding the outer surface of the cable tube 311. In one embodiment, the proximal portion 310 p made of the cable tube 311 can provide significantly greater torque transfer and indentation than the distal end portion 310 d made of the coil 310 c . Conversely, the distal end portion (310 d) may be holy more flexible than the proximal portion (310 p).

In some embodiments, the coil (310 c) has a length in the range 5 to 15 ㎝, cable tubes (that is, the proximal portion (310 p)) is a length of 60 to 100 ㎝. One or more illumination channels for the illumination fibers 310 i are provided in the guide wire 310 and extend along its length. The illumination channel is configured to transport light from the proximal end of the illumination guide wire 310 to and away from the distal end of the device. One or more illumination channels may each be provided that includes plastic illuminated fibers. As previously described, the plastics used to make the illuminating fibers are blended for light transfer properties in accordance with techniques known in the art and available in the art. Therefore, Eska (Mitsubishi Rayon) high performance plastic optical fiber having a concentric two-layer structure with a high purity polymethyl methacrylate (PMMA) core and a thin layer of specially selected transparent fluoropolymer cladding can be used. In a preferred approach, the assemblies include two illuminating fibers each having an outer diameter of about 0.254 mm (0.010 &quot;). However, the illuminating fibers may have an outer diameter in the range of about 0.127 mm (0.005 inch) to about 0.254 mm Alternatively, a single plastic illuminating fiber having an outer diameter of about 0.508 mm (0.020 &quot;) may be used. Also, glass illumination fibers with much smaller outer diameter, e.g., about 0.051 mm (0.002 &quot;), can be substituted. In this case, more of the illuminating fibers can be provided in bundles, for example about 6 to 50 glass fibers can be provided.

In some embodiments, the guidewire 310 may also include an inner core wire 310 cw (or " core wire &quot;) in some cross-sections and may include a distal end 310 d of the distal portion 310 d of the guidewire 310 and from can be extended to the proximal end of the proximal section (310 p), at the distal end, a coil (310 c) and a cable tube 311 at the joint between, and a coil at the proximal end portion (310 c) and a cable tube (311 ). &Lt; / RTI &gt; In various embodiments, the core wire 310 cw may be attached by any suitable means, such as laser welding, epoxy or other adhesive or mechanical fastener. In one embodiment, the core wire 310 cw may be formed of a Nitinol (nickel-titanium alloy) metal alloy that is biocompatible and provides the required stiffness and torque transfer. In the preferred embodiment discussed below, the core wire 310 cw is terminated at approximately mid-point through the device 310 having a fixed distal end and a negative end (i.e., fixed or unjoined) proximal end. As will be discussed in the following description, the core wire (310 cw) can be joined at various other points along the apparatus 310 such as that identified by 301 sj1, sj2 301 and 301 sj3.

The core wire 310 cw alone is highly flexible and particularly increases the ease of indentation and torque transfer of the torsional coil 310 c . In combination with the core wire (310 cw), the distal portion (310 d) is much more effective for passing the press-in force and torque applied without buckling or twisting. In addition, the core wire 310 cw can be plastically deformed or memorized in a curved shape, allowing the operator to direct the distal end of the device 310 in a different direction by applying a torque to the device about the longitudinal axis of the device do.

Similar to Figs. 27 and 28, the core wire 310 cw may be formed as a long member. When so formed, the core wire 310 cw can be ground to different diameters to provide a varying amount of rigidity and torque transfer along the illumination guide wire 310. As part of the illumination guide wire 310 assembly, the core wire 310 cw is configured to provide space for the illumination fibers 310 i . Thus, the major dimension of the core wire 310 cw should be less than the inner diameter of the proximal portion 310 p .

37A-37F illustrate axial cross-sectional views of the guide wire 310 along various points along the length of the device, and illustrate components that are included within the various points of the guide wire 310. As shown in Fig.

As shown in Fig 37aa showing the distal region of the coil guide wire 310, it is housed in the illumination fiber (310 i) and a core wire (310 cw) a coil (310 c). In reference to Figure 37 and again as mentioned, the distal end of the light guide wire 310 is transparent, which may be in the form of an epoxy or other transparent or translucent adhesive or a sealing material (or translucent), the seal (310 s) Respectively. The seal (310 s) and will maintain the distal end of the illumination fiber (310 i) that match the distal end of the device, provides a lens 313 to provide a non-traumatic tip. In one approach, UV adhesive is employed to bond to the illumination fiber (310 i) a coil (310 c) and the core wire (310 cw). In addition, the seal (310 s) will prevent the introduction of foreign matter into the apparatus. The lens 313 formed at the distal end may be designed to focus or distribute light when light is emitted therefrom in order to achieve a maximum transmitted illumination effect. The distal end may also include a prism or diffractive element. Also, 310 sj1 represents a solder joint, wherein the same type of braze material as described herein before is suitable for use in 310 sj1 . Junction of the coil (310 c) and the core wire (310 cw) can be made by mechanical joints or by laser welding in an epoxy (or other adhesive).

When the coil (310 c), the cable tube 311, with reference to the guide also 37bb and 37cc representing the area of the wire 310 including the transition section of the illumination from, can see the twisted pair wires (310 sw). After, as will be seen in the discussion of the drawings, following, the stranded wire (310 sw) has a function of absorbing the load to be passed further to a weak one trillion people fiber (310 i) if and otherwise, providing the stress relaxation in the system. The twisted wire 310 sw may be made of any flexible, medically safe material that can be braided together but provides sufficient tensile strength to withstand sudden pulling or pulling. Such materials include stainless steel and nitinol.

In a preferred embodiment, the stranded wire 310 sw has a total diameter of approximately 0.005 inch (0.127 mm). By varying the number and thickness of the strands comprising the stranded wire 310 sw , the flexibility and ability to bend (beat) the illuminating wire 310 is achieved. In the most preferred embodiment, 19 strands of stainless steel having a diameter of approximately 0.001 inch (0.001 inch) or 19 strands of stainless steel having a diameter of approximately 0.025 mm (0.001 inch) are satisfactory to withstand sudden pulling or traction Strength and Flexibility Provides ability to twist during use and use.

37D shows a portion of the lighting device 310 near the proximal end of the device. In this figure, the core wire 310 cw no longer exists, because in this embodiment it is terminated at a position before it reaches the proximal end of the device. The end point is similar to the end point 261 of the above-described embodiment shown in Fig.

Figures 37ee and 37ff illustrate another transition region within the proximal region of the illumination device 310. [ In particular, the cable tube 311 can then be shown to be in the unit type tube (310 ft) in Figure 37ee a transition, Fig. 37ff in absent the cable tube 311, and the union (310 bt) is also 37ff As shown.

The negative tubing 310 ft serves to provide a surface on which the illumination guide wire 310 is gripped or otherwise engaged by the locking or locking mechanism of the optical connector. The negative tubing 310 ft is fixedly joined at its proximal end (as shown in Figure 38c), but is allowed to " float " at its distal end (i.e., as shown in Figure 38b, ). Thus, the negative tubing 310 ft allows the twisted wire 310 sw and the illumination fibers 310 i to twist within the illumination device 310. The ability of the twisted wire 310 sw and the light fibers 310 i to twist is very advantageous because the device will typically be pivoted when in use, typically in a sinus cavity, such as it is present in the sinus.

The negative tubing 310 ft may be made of any suitable, medically safe material that will provide sufficient stiffness and strength to receive the various internal elements of the illumination guide wire 310 and to sustain engagement with the optical connector . Examples of such materials are those used to manufacture hypotubes for medical applications, including stainless steel, titanium, elyellow and PEEK tubing.

The junction tube 310 bt functions to securely fasten the elements of all the illumination guide wires 310 present at the proximal end of the device as described in the discussion of Figure 38c.

The junction tube 310 bt is configured to receive various internal elements of the illumination guide wire 310 and to provide a seal for the junction material (e.g., epoxy or other medically safe adhesive) for joining internal elements within the proximal end of the device. It may be any suitable, medically safe material that provides sufficient rigidity and strength to provide a surface. Examples of such medically safe materials include block copolymers such as those sold under the trade name Pebax, nylon, polycarbonate, polyimide and other plastics such as acrylonitrile-butadiene-styrene copolymer (ABS).

Fig. 38 provides an overview in which the main transition occurs along the length of the lighting device 310. Fig. Figures 38a, 38b and 38c show details of a specific area or area of the device.

Referring to Figure 38a, there is a transition between the coil (310 c) and a cable tube 311 is shown. In this embodiment, the illumination fiber (310 i) is passed through the zone. Cable tube 311 is bonded to the coil (310 c), the twisted pair wires (310 sw) and the core wire (310 cw) by a solder joint (310 sj3). In addition, bonding the solder joint (310 sj2) a coil (310 c), the twisted pair wires (310 sw) and the core wire (310 cw). Implications of having these two junctions is the cable tube 311 and the coil (310 c), not only proven to ensure a smooth transition, almost natural bending curve, that is, the area to form any severe bending without bending curve between Thereby improving the bendability. Preferably, the braze joint (310 sj2) and the braze joint (310 sj3) distance ㎜ 0.508 to 1.524 (0.020 to 0.060 inches) in the range. If it is less than the braze joint (310 sj2) and the braze joint distance is 0.508 ㎜ (0.020 inches) between (310 sj3), this section being too rigid, and has less natural bending when bent. If the distance is greater than 1.524 mm (0.060 inches), the area becomes too flexible and is not rigid enough to advance the guide wire without bending. In general, it has been determined that the bending of such areas without severe bending is a range of about one to four times the outer diameter of the portion of the housing to be joined, more preferably three times the outer diameter of the portion of the housing to be joined.

Figure 38b shows the transition between the cable tube 311 and the negative tubing 310 ft . Of particular importance in this figure cable tube 311 (and thus its contents, i.e. one trillion people fiber (310 i) and the twisted pair wires (310 sw)) that they are not fixed to the sub-type pipe joint (310 ft). Thus, the cable tube 311 and its contents are free to rotate about the negative tubing 310 ft , which is a desirable feature when traversing the sinuous river of the sinus.

Finally, Fig. 38C shows the configuration of the proximal end of the illumination device 310. Fig. In this figure, the proximal end portion (one or semi) transparent, which may be in the form of an epoxy or other transparent or translucent adhesive or sealing material seal (310 s) (similar to that on the distal end) of the light guide wire (310) Respectively. It provides a seal (310 s) the lens (310 pl) in order to keep the proximal end of the illumination fiber (310 i) that matches the proximal end of the device and provide a non-traumatic tip. Applied in In one approach, the UV adhesive is employed, the illumination fiber (310 i), the union (310 bt) and the twisted pair wires (310 sw) seal (310 s) the adhesive region (310 ad1) to bond the do. In addition, the seal (310 s) will prevent the introduction of foreign matter into the apparatus. The lens 310pl formed at the proximal end can be designed to focus or distribute light when light is received from an optical cable or other light source to achieve a maximum transmission illumination effect. Figure 38c also shows the proximal end of the pouch tubing 310 ft secured to the junction tube 310 bt . Although any suitable bonding method can be used to bond the negative tubing 310 ft to the junction tube 310 bt , the use of a medically safe adhesive is preferred and is provided in the adhesive area 310 ad2 , Can be bonded to the bonding material used for the bonding area 310 ad1 .

It has been observed that a lighting connector, i.e. a device which bonds the light guide wire device to the optical cable of the light source, is vulnerable to heating which may be detrimental to the effectiveness of the lighting device which provides adequate illumination at the distal end and the components of the illuminated guide wire. In some cases, temperatures in excess of 250 ° F have been observed. The lighting connector described below helps to better control heat accumulation.

39 shows a lighting connector 320 that includes a body 322, a button 330, and a button spring 332. As shown in Fig. The body 332 generally includes a conical distal bore 328, a central bore 326, and an optical cable connection receptacle 324. Button 330 also includes a bore 334. In use, the connector 320 receives the illumination guide wire 310 through the distal bore 328. While pushing the button 330 downward, the illumination guide wire 310 is further advanced through the button bore 334 until it reaches the proximal opening 340. The illumination guide wire 310 is secured within the connector 320 when the button 330 is released and the spring 332 is engaged with the negative bore 334 when the button bore 334 is pressed against axial alignment with the central bore 326 310 ft . &Lt; / RTI &gt; As previously mentioned, the cable tube 311 and its contents can be rotated by the negative tubing 310 ft , which is the section of the lighting device 310 secured within the connector 320.

Figure 39A includes additional details of the proximal end of the connector 320. [ In particular, the illumination device 310 lies within the aperture 340. It is important that the diameter of the opening 340 is less than the diameter of the proximal end of the illuminated device 310. An aperture diameter in the range of about 60% to about 80% (preferably about 70%) of the outer diameter of the proximal end of the illumination device provides satisfactory photodissociation while maintaining sufficient light transmission to the distal end of the device through the illumination fiber . Another notable feature of the connector 320 is that the proximal lens 310pl does not protrude out of the aperture 340 (to avoid direct contact with the light source) and the inclined portion 342 inside the central bore 326 It is. These features further help to maintain the reliable operation of the illuminated guide wire by preventing the excess light from dissipating the false light transmitted through the optical cable of the strong light source to be converted into heat. These features also allow for consistent light output from a light source that produces a small amount of light.

It should be noted that having a body 320 made of translucent material aids in erroneous light dissipation. Preferably, the body 320 is made of a translucent material having a translucency of 70% or greater. These translucency levels are readily obtained from medically safe plastics and can be adjusted to include varying levels of dye to achieve the desired translucency.

This has been observed that the thermal cycles can be applied to the illumination fiber (310 i). This is due to sterilization, aging, transport, fiber illumination and other factors. Such thermal cycling can cause the longitudinal shrinkage of the illumination fiber (310 i). In fact, 0.5 to 1% shrinkage can occur when the illuminating fiber is heated to 40 DEG C or higher. In conventional approaches, illumination fiber shrinkage can cause damage if the fiber is secured in a manner that does not compensate for shrinkage. The ends of the fibers may be torn or worn, thereby adversely affecting the function of the fibers.

Various approaches are considered to deal with the contraction of the illuminating fiber. In one approach, the fibers can be pre-heat treated at about 70 캜 for 48 hours. By doing so, the fibers can be pre-contracted. This may minimize or eliminate further shrinkage at lower temperatures.

In another contemplated approach for compensating for variations in the length of the illumination fiber, the core wire may alternatively or additionally be foldable and may include a structure such as a spring or corrugated section. The core wire may also be cut elsewhere to accommodate length variations.

The disclosed light guide wire assembly can be used in numerous applications. In addition to use in the sinus, the assembly can be employed in vascular applications, for example, by providing a way to map it or aid its diagnosis while it is advanced through an anatomical structure. In addition, the device may be useful for illuminating deep tissue, or may be used within the gastrointestinal tract for similar purposes.

Furthermore, while the present invention has been described with reference to specific embodiments thereof, it will be appreciated that various changes can be made and equivalents substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps to the purpose, spirit, and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto.

Claims (20)

As an illumination guide wire device,
The elongate flexible housing having a proximal end, a distal end adapted to be disposed in a region within a patient's body, and a distal end extending from the proximal end to the distal end The housing having a lumen, the housing comprising at least a first portion of the first material and a second portion of the second material, the first portion and the second portion being joined together by a first joint and a second joint, The long flexible housing being joined;
At least one illuminating fiber extending through the lumen of the housing;
At least one support member extending through a lumen of the housing in which at least the first joint and the second joint are located, the first joint joining the first portion of the housing to the support member, The joint comprising at least one support member for joining a first portion of the housing to a second portion of the housing and a support member. The lighting guide wire arrangement of claim 1, wherein the first housing comprises a coil and the second housing comprises a cable duct. 3. The illumination guide wire apparatus of claim 2, wherein the at least one illuminating fiber comprises at least two illuminating fibers. The lighting guide wire apparatus according to claim 3, wherein the supporting member is a core wire. 5. The illumination guide wire apparatus of claim 4, further comprising a stranded wire extending through the lumen of the housing. 6. The illumination guide wire apparatus of claim 5, wherein the twisted wire is secured to a proximal end of the housing and is attached to the housing at the first joint and the second joint. 7. The method of claim 6 wherein the core wire is attached to the housing at a distal end of the housing and extends proximally from the first and second joints but does not extend completely to the proximal end of the housing, And the proximal end of the core wire is not attached to the housing. 8. The lighting guide wire arrangement of claim 7, wherein the first joint and the second joint are spaced apart along the housing by a distance in the range of approximately one-four to four times the outer diameter of the housing. The lighting guide wire apparatus according to claim 8, wherein the distance is ½ to 3 times the outer diameter of the housing. 2. The apparatus of claim 1, wherein the illumination guidewire device comprises a proximal assembly,
A first tube having a lumen extending through the first tube; And
A second tube having a lumen through the second tube and located within the lumen of the first tube at a proximal end and extending beyond a proximal end of the first tube but extending beyond a distal end of the first tube; Said second tube,
Said elongated flexible housing being received within said first tube but extending in a proximal direction beyond said proximal end of said first tube,
Wherein the at least one illumination fiber extends through the lumen of the housing and the lumen of the first tube in a proximal direction beyond the lumen of the housing and the lumen of the first tube and into the lumen of the second tube,
Wherein the housing is not fixedly attached to the first tube but rotates freely within the first tube, and the distal end of the second tube and the proximal end of the first tube are fixedly attached. 11. The illumination guide wire apparatus according to claim 10, wherein the housing is a cable tube. 12. The illumination guide wire apparatus according to claim 11, wherein the first tube is a hypotube. 13. The lighting guide wire apparatus according to claim 12, wherein the second tube is made of a block copolymer resin. 14. The method of claim 13, further comprising: passing through the lumen of the housing and the lumen of the first tube, in a proximal direction beyond the lumen of the housing and the lumen of the first tube and into a lumen of the second tube, The light guide wire device further comprising: 15. The lighting guide wire apparatus of claim 14, further comprising an adhesive lens fixedly attached to the proximal end of the second tube and fixedly attached to the at least one illuminating fiber. 16. The illumination guide wire apparatus of claim 15, wherein the at least one illumination fiber comprises at least two illumination fibers. A connector configured to receive the light guide wire device according to any one of claims 1 to 16,
Proximal portion;
Distal portion; And
And a bore extending through the proximal portion and the distal portion and having a diameter less than a diameter of the outer diameter of the light guide wire device at the proximal portion. 18. The connector of claim 17 wherein the proximal portion of the bore terminates at an aperture.  19. The connector of claim 18, wherein the diameter of the opening is 60-80% of the outer diameter of the light guide wire arrangement.  20. The connector of claim 19, wherein the distal end of the bore is conical.

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